| Date
Issued |
Title |
Pages |
Doc
(.pdf) |
| 12/23/99 |
Precautionary
Measures to Reduce the Possible Risk of Transmission
of Zoonoses by Blood and Blood Products from Xenotransplantation
Product Recipients and Their Contacts (DRAFT) |
11 |
 |
| 12/21/99 |
Guidance
for Industry: Special Protocol Assessment (DRAFT) FDA199912E |
12 |
|
| 12/14/99 |
In
the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency
Viruses Types 1 and 2 FDA199912B |
24 |
|
12/7/99 |
Pharmacokinetics
in Patients With Impaired Hepatic Function: Study Design,
Data Analysis and Impact on Dosing and Labeling (DRAFT) FDA199912A |
20 |
|
12/1/99 |
Postmarketing
Studies for Human Drugs and Licensed Biological Products;
Status Reports (Federal Register Document - Proposed Rule) FDA199912D |
10 |
|
| 11/24/99 |
In
Vivo Drug Metabolism / Drug Interaction Studies - Study
Design, Data Analysis and Recommendations for Dosing and
Labeling |
19 |
|
| 11/23/99 |
Revised
Precautionary Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease (CJD) and New
Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and
Blood Products |
18 |
|
| 11/22/99 |
Providing
Regulatory Submissions to the Center for Biologics Evaluation
and Research (CBER) in Electronic Format - Biologics Marketing
Applications [Biologics License Application (BLA), Product
License Application (PLA) / Establishment License Application
(ELA) and New Drug Application (NDA)] (REVISED) FDA199911B
CBER
Computer Assisted License Application (CALA) Questionnaire
(PDF) |
65 |
|
| 11/3/99 |
Supplemental
Guidance on Testing for Replication Competent Retrovirus
in Retroviral Vector Based Gene Therapy Products and During
Follow-up of Patients in Clinical Trials Using Retroviral
Vectors (DRAFT) FDA199911A |
16 |
|
| 10/99 |
Classifying
Resubmissions in Response to Action Letters; CDER DA199910D |
4 |
|
| 10/20/99 |
Biological
Products Regulated Under Section 351 of the Public Health
Services Act; Implementation of Biologics License; Elimination
of Establishment License and Product License (Federal
Register Document - Proposed Rule) FDA199910C |
14 |
|
| 10/8/99 |
Guidance
for Industry: Qualifying for Pediatric Exclusivity Under
Section 505A of the Federal Food, Drug and Cosmetic Act FDA199910A |
25 |
|
| 10/5/99 |
New
Drug and Biological Products; Evidence Needed to Demonstrate
Efficacy of New Drugs for Use Against Lethal or Permanently
Disabling Toxic Substances When Efficacy Studies in Humans
Ethically Cannot Be Conducted (Federal Register Document
- Proposed Rule) FDA199910Ffr |
11 |
|
| 10/5/99 |
Human
Drugs and Biologics; Determination That Informed Consent
Is NOT Feasible or Is Contrary to the Best Interests of
Recipients; Revocation of 1990 Interim Final Rule; (Federal
Register Document - New Interim Final Rule) FDA199910Efr |
11 |
|
| 9/30/99 |
Suitability
Determination for Donors of Human Cellular and Tissue-Based
Products; (Federal Register Document - Proposed Rule) FDA199909Dfr |
28 |
|
| 9/24/99 |
International
Conference on Harmonisation Draft Guidance; Choice of
Control Group in Clinical Trials (Federal Register Document
- Notice) FDA199909C |
14 |
|
| 9/13/99 |
Guidance
for Industry: Submission of Abbreviated Reports and Synopses
in Support of Marketing Applications FDA199909B |
15 |
|
| 9/1/99 |
Guidance
for Industry: Revised Recommendations for the Invalidation
of Test Results When Using Licensed and 510(k) Cleared
Bloodborne Pathogen Assays to Test Donors (DRAFT) FDA199909A |
9 |
|
| 8/27/99 |
Guidance
for Industry: Possible Dioxin/PCB Contamination of Drug
and Biological Products FDA199908F |
4 |
|
| 8/18/99 |
Q6B
International Conference on Harmonisation (ICH); Guidance
on Specifications: Test Procedures and Acceptance Criteria
for Biotechnological/Biological Products (Federal Register
Document - Notice) FDA199908Efr |
8 |
|
| 8/17/99 |
Guidance
for Industry Information Request and Discipline Review
Letters Under the Prescription Drug User Fee Act (DRAFT) FDA199908D |
8 |
|
| 8/17/99 |
Guidance
for Industry: Revised Precautionary Measures to Reduce
the Possible Risk of Transmission of Creutzfeldt-Jakob
Disease (CJD) and New Variant Creutzfeldt-Jakob Disease
(nvCJD) by Blood and Blood Products FDA199908C |
17 |
|
| 8/6/99 |
Guidance
for Industry Consumer-Directed Broadcast Advertisements FDA199908B |
6 |
|
| 8/3/99 |
Cooperative
Manufacturing Arrangements for Licensed Biologics (DRAFT) FDA199908A |
13 |
|
| 7/24/99 |
Interpreting
Sameness of Monoclonal Antibody Products Under the Orphan
Drug Regulations (DRAFT) FDA199907C |
7 |
|
| 7/15/99 |
Draft
Guidance for Industry: Clinical Development Programs for
Drugs, Devices, and Biological Products Intended for the
Treatment of Osteoarthritis (OA) (DRAFT) FDA199907B
Previous
Version:
| Draft 2/12/98 |
FDA199802B |
|
|
12 |
|
| 7/7/99 |
Container
Closure Systems for Packaging Human Drugs and Biologics
FFCC99 |
56 |
|
| 6/28/99 |
Supplements
and Other Changes to an Approved Application FDA199906Efr |
18 |
|
| 6/25/99 |
S4A
ICH Guidance on the Duration of Chronic Toxicity Testing
in Animals (Rodent and Nonrodent Toxicity Testing); Availability |
2 |
|
| 6/25/99 |
Monoclonal
Antibodies Used as Reagents in Drug Manufacturing FDA199906D |
17 |
|
| 6/17/99 |
Current
Good Manufacturing Practice for Blood and Blood Components:
(1) Quarantine and Disposition of Prior Collections from
donors with Repeatedly Reactive Screening Tests for Hepatitis
C Virus (HCV); (2) Supplemental Testing, and the Notification
of Consignees and Transfusion Recipients of donor Test
Results for Antibody to HCV (Anti-HCV) FDA199906C |
28 |
|
| 6/4/99 |
Establishing
Pregnancy Registries (DRAFT) FDA199906B |
26 |
|
| 6/4/99 |
Evaluation
of Human Pregnancy Outcome Data FDA199906A |
34 |
|
| 5/20/99 |
Guidance
for Industry: Efficacy Studies to Support Marketing of
Fibrin Sealant Products Manufactured for Commercial Use FDA199905D |
5 |
|
| 5/20/99 |
Guidance
for Industry: For Platelet Testing and Evaluation of Platelet
Substitute Products (DRAFT) FDA199905C |
9 |
|
| 5/14/99 |
Revision
of Requirements Applicable to Albumin (Human), Plasma
Protein Fraction (Human), and Immune Globulin (Human);
(Federal Register Document - Direct Final Rule) FDA199905Efr |
6 |
|
| 5/10/99 |
Guidance
for Industry: Computerized Systems Used in Clinical Trials FDA199905B |
10 |
|
| 5/10/99 |
Guidance
for Industry: For the Submission of Chemistry, Manufacturing
and Controls and Establishment Description Information
for Human Blood and Blood Components Intended for Transfusion
or for Further Manufacture and For the Completion of the
Form FDA 356h “Application to Market a New Drug,
Biologic or an Antibiotic Drug for Human Use” FDA199905A
Previous
Version:
Draft 7/9/98 |
FDA199807B |
|
|
33 |
|
| 4/23/99 |
Guidance
for Industry on the Content and Format of Chemistry, Manufacturing
and Controls Information and Establishment Description
Information for an Allergenic Extract or Allergen Patch
Test FDA199904C
Previous
Version:
Draft 8/27/98 |
FDA199808C |
|
|
27 |
|
| 4/20/99 |
Investigational
New Drug Applications; Clinical Holds; Confirmation of
Effective Date (Federal Register Document - Direct Final
Rule; Confirmation of Effective Date) FDA199904Bfr
Corresponding
Documents:
| Direct Final 12/14/98 |
FDA199812Afr |
|
| Proposed 12/14/98 |
FDA199812Bfr |
|
|
1 |
|
| 3/19/99 |
Guidance
for Industry: Formal Meetings With Sponsors and Applicants
for PDUFA Products (DRAFT) FDA199903D |
13 |
|
| 3/19/99 |
Guidance
for Industry Formal Dispute Resolution: Appeals Above
the Division Level (DRAFT) FDA199903C |
12 |
|
| 3/11/99 |
|
7 |
|
| 3/8/99 |
Guidance
for Industry: Content and Format of Chemistry, Manufacturing
and Controls Information and Establishment Description
Information for a Biological In Vitro Diagnostic Product
Previous
Version:
Draft 11/10/98 FDA199811A |
|
|
22 |
|
| 2/17/99 |
Guidance
for Industry: Clinical Development Programs for Drugs,
Devices and Biological Products for the Treatment of Rheumatoid
Arthritis (RA) FDA199902C
Previous
Versions:
Draft 3/18/98 |
FDA199803C |
|
Draft 1/6/97 |
FDA199701B |
|
|
50 |
|
| 2/17/99 |
Guidance
for Industry: For the Submission of Chemistry, Manufacturing
and Controls and Establishment Description Information
for Human Plasma-Derived Biological Products or Animal
Plasma or Serum-Derived Products FDA199902B
Previous
Version:
| Draft 12/25/97 |
FDA199712A |
|
|
19 |
|
| 2/99 |
INDs
for Phase 2 and 3 Studies of Drugs, Including Specified
Therapeutic Biotechnology-Derived Products; Chemistry,
Manufacturing, and Controls Content and Format (DRAFT) FDA199904A |
18 |
|
|
|
|
|
| 2/10/99 |
Guidance
for Industry: Population Pharmacokinetics FDA199902D |
35 |
|
| 2/3/99 |
FDA
Approval of New Cancer Treatment Uses for Marketed Drug
and Biological Products FDA199902A
Previous
Version:
| Draft 3/13/97 |
FDA199703A |
|
|
10 |
|
| 1/29/99 |
Guidance
for Industry: Providing Regulatory Submissions in Electronic
Format - NDAs FDA199901E
Previous
Version:
Draft 5/13/98 |
FDA199804D |
|
|
74 |
|
| 1/28/99 |
Providing
Regulatory Submissions in Electronic Format - General
Considerations FDA199901D
Previous
Versions:
| Draft 5/13/98 |
|
| Draft 5/13/98 |
|
| Draft 5/13/98 |
|
| Draft 5/13/98 |
|
| Draft 11/4/96 |
|
| Draft 11/4/96 |
|
|
17 |
|
| 1/26/99 |
Guidance
on Amended Procedures for Advisory Panel Meetings FDA199901C |
5 |
|
| 1/21/99 |
Guidance
for Industry: Content and Format for Geriatric Labeling FDA199901B |
13 |
|
| 1/5/99 |
Guidance
for Industry: Content and Format of Chemistry, Manufacturing
and Controls Information and Establishment Description
Information for a Vaccine or Related Product FDA199901A
Previous
Version:
| Draft 6/18/98 |
FDA199806E |
|
|
34 |
|
Date
Issued |
Title |
Pages |
Doc
(.pdf) |
12/14/98 |
Bioanalytical
Methods Validation for Human Studies (DRAFT) (CDER) FDA199812C) |
16 |
|
12/14/98 |
Investigational
New Drug Applications; Clinical Holds (Federal Register
Document - Direct Final Rule) FDA199812Afr) |
3 |
|
12/14/98 |
Investigational
New Drug Applications; Clinical Holds (Federal Register
Document - Companion Document to Direct Final Rule) FDA199812Bfr) |
3 |
|
11/30/98 |
Guidance
for Industry: General Considerations for Pediatric Pharmacokinetic
Studies for Drugs and Biological Products (DRAFT) FDA199811D |
11 |
|
11/24/98 |
FDA
Plan for Statutory Compliance (Federal Register Document
- Notice) FDA199811Gfr |
42 |
|
11/24/98 |
Food
and Drug Administration Modernization Act of 1997: FDA
Plan for Statutory Compliance FDA199811G |
75 |
|
11/24/98 |
Import
for Export; Reporting and Record keeping Requirements
for Unapproved or Violative Products Imported for Further
Processing or Incorporation and Subsequent Export (Federal
Register Document - Proposed Rule) FDA199811Ffr |
8 |
|
11/20/98 |
Dissemination
of Information on Unapproved/New Uses for Marketed Drugs,
Biologics, and Devices (Federal Register Document - Final
Rule) FDA199811Efr |
34 |
|
11/19/98 |
Guidance
for Industry: In Vivo Drug Metabolism/Drug Interaction
Studies - Study Design, Data Analysis, and Recommendations
for Dosing and Labeling (DRAFT) FDA199811C |
18 |
|
11/18/98 |
Guidance
for Industry: Fast Track Drug Development Programs - Designation,
Development, and Application Review FDA199811B
| Appendix
1: |
Section
112 of the FDAMA of 1997 |
Within
guidance |
| Appendix
2: |
Procedures
for Drugs Intended to Treat Life-Threatening and
Severely Debilitatiing Ilnesses (10/21/88) |
|
| Appendix
3: |
Priority
Review Policies (SOPP 8405) |
|
| Appendix
4: |
Accelerated
Approval of New Drugs and Biological Products for
Serious or Life-Threatening Illnesses (MAPP 6020.3) |
|
|
56 |
|
11/10/98 |
Guidance
for Industry: Content and Format of Chemistry, Manufacturing
and Controls Information and Establishment Description
Information for a Biological In Vitro Diagnostic
Product (DRAFT) FDA199811A |
20 |
|
10/30/98 |
Guidance
for Industry: Advisory Committees: Implementing Section
120 of the Food and Drug Administration Modernization
Act of 1997 FDA199810B |
9 |
|
10/14/98 |
Guidance
for Industry: Developing Medical Imaging Drugs and Biologics
(DRAFT) FDA199810A |
46 |
|
10/2/98 |
Draft Guidance for Industry: Submitting Debarment Certification Statements |
15 |
|
9/24/98 |
Q5A
ICH Guidance on Viral Safety Evaluation of Biotechnology
Products Derived From Cell Lines of Human or Animal Origin |
11 |
|
9/21/98 |
ICH
Guidance on Quality of Biotechnological/Biological Products:
Derivation and Characterization of Cell Substrates Used
for Production of Biotechnological/Biological Products |
6 |
|
9/16/98 |
E9
ICH Guidance on Statistical Principles for Clinical Trials |
16 |
|
9/8/98 |
Guidance
for Industry: How to Complete the Vaccine Adverse Event
Reporting System Form (VAERS-1) FDA199809A |
21 |
|
9/4/98 |
Guidance
for Industry: Investigating Out of Specification (OOS)
Test Results for Pharmaceutical Production; CDER (DRAFT) FDA199809B |
13 |
|
8/27/98 |
Guidance
for Industry: On the Content and Format of Chemistry,
Manufacturing and Controls Information and Establishment
Description Information for an Allergenic Extract or Allergen
Patch Test (DRAFT) FDA199808C |
28 |
|
8/11/98 |
Biological
Products Regulated Under Section 351 of the Public Health
Services Act; Implementation of Biologics License; Elimination
of Establishment License and Product License (Federal
Register Document - Proposed Rule) FDA199808Bfr |
2 |
|
8/5/98 |
Revisions
to the General Safety Test Requirements for Biological
Products (Federal Register Document - Direct Final Rule) FDA199808Afr
Previous
Versions:
Final 4/20/98 FDA199804Afr |
|
Proposed 4/20/98 FDA199804Bfr |
|
|
1 |
|
7/31/98 |
Biological
Products Regulated Under Section 351 of the Public Health
Services Act; Implementation of Biologics License; Elimination
of Establishment License and Product License (Federal
Register Document - Proposed Rule) FDA199807Efr |
14 |
|
7/27/98 |
Guidance
for Industry: Environmental Assessment of Human Drug and
Biologics Applications FDA199807D
Previous
Version:
Draft 11/97 FDA199711A |
|
|
41 |
|
7/21/98 |
Guidance
for Industry: Implementation of Section 126 of the Food
and Drug Administration Modernization Act of 1997 - Elimination
of Certain Labeling Requirements FDA199807C
Previous
Version:
Draft 2/98 FDA199802A |
|
|
6 |
|
7/9/98 |
Guidance
for Industry: For the Submission of Chemistry, Manufacturing
and Controls and Establishment Description Information
for Human Blood and Blood Components Intended for Transfusion
or for Further Manufacture and For the Completion of the
FDA Form 356h “Application to Market a New Drug,
Biologic or an Antibiotic Drug for Human Use” (DRAFT) FDA199807B |
28 |
|
7/9/98 |
Guidance
for Industry: In the Manufacture and Clinical Evaluation
of In Vitro Tests to Detect Nucleic Acid Sequences
of Human Immunodeficiency Virus Type 1 (DRAFT) FDA199807A |
17 |
|
7/1/98 |
PDUFA
II: Five - Year Plan; 1998 - 1999 - 2000 - 2001
- 2002 FDA199807F
Other
PDUFA Documents:
|
76 |
|
6/29/98 |
Guidance
for Industry: Qualifying for Pediatric Exclusivity Under
Section 505A of the Federal Food, Drug and Cosmetic Act FDA199806F |
19 |
|
6/18/98 |
Guidance
for Industry: Content and Format of Chemistry, Manufacturing
and Controls Information and Establishment Description
Information for a Vaccine or Related Product FDA199806E |
34 |
|
6/12/98 |
Draft
Guidance for Industry: Exports and Imports Under the FDA
Export Reform and Enhancement Act of 1996 (Federal Register
Document - Notice) FDA199806Dfr |
16 |
|
6/11/98 |
Guidance
for Industry: Errors and Accidents Regarding Saline Dilution
of Samples Used for Viral Marker Testing FDA199806C |
3 |
|
6/10/98 |
E5
ICH Guidance on Ethnic Factors in the Acceptability of
Foreign Clinical Data |
7 |
|
6/8/98 |
Dissemination
of Information on Unapproved/ New Uses for Marketed Drugs,
Biologics, and Devices (Federal Register Document - Proposed
Rule) FDA199806Bfr |
19 |
|
6/8/98 |
Guidance
for Industry: Stability Testing of Drug Substances and
Drug Products (DRAFT) F*Withdrawn 6/1/06 A199806A
Corresponding ICH Document:
|
114 |
|
5/15/98 |
Guidance
for Industry: Standards for the Prompt Review of Efficacy
Supplements, Including Priority Efficacy Supplements FDA199805G |
4 |
|
5/15/98 |
Guidance
for Industry: Providing Clinical Evidence of Effectiveness
for Human Drugs and Biological Products FDA199805F
Previous
Version:
Draft 3/13/97 FDA199703B |
|
|
22 |
|
5/15/98 |
Guidance
for Industry: Pharmacokinetics in Patients with Impaired
Renal Function - Study Design, Data Analysis, and Impact
on Dosing and Labeling FDA199805E |
17 |
|
5/14/98 |
Establishment
Registration and Listing for Manufacturers of Human Cellular
and Tissue-Based Products; (Federal Register Document
- Proposed Rule) FDA199805Kfr |
12 |
|
5/14/98 |
Guidance
for Industry: Classifying Resubmissions in Response to
Action Letters FDA199805D |
4 |
|
5/14/98 |
Guidance
for Industry: Submitting and Reviewing Complete Responses
to Clinical Holds FDA199805C |
4 |
|
5/13/98 |
Guidance
for Industry: Electronic Submissions of a Biologics License
Application (BLA) or Product License Application (PLA)/
Establishment License Application (ELA) to the Center
for Biologics Evaluation and Research FDA199805A |
47 |
|
5/13/98 |
Guidance
for Industry: Pilot Program for Electronic Investigational
New Drug (eIND) Applications for Biological Products FDA199805B |
30 |
|
5/13/98 |
Guidance
for Industry: Instructions For Submitting Electronic Lot
Release Protocols to the Center for Biologics Evaluation
and Research (DRAFT) FDA199805I |
8 |
|
5/13/98 |
Guidance
for Industry: Electronic Submissions of Case Report
Forms (CRFs), Case Report Tabulations (CRTs) and Data
to the Center for Biologics Evaluation and Research
(DRAFT) FDA199805
Previous
Version:
Draft 11/4/96 FDA199611B |
|
|
35 |
|
4/20/98 |
Revisions
to the General Safety Requirements for Biological Products;
Companion Document to Direct Final Rule (Federal Register
Document - Proposed Rule) FDA199804Bfr |
4 |
|
4/20/98 |
Revisions
to the General Safety Requirements for Biological Products
(Federal Register Document - Final Rule) FDA199804Afr |
5 |
|
4/17/98 |
Guidance
for Industry: Manufacturing, Processing, or Holding Active
Pharmaceutical Ingredients (DRAFT) FDA199804C |
57 |
|
4/6/98 |
Guidance
for Industry: Providing Regulatory Submissions in Electronic
Format - NDAs FDA199804D |
45 |
|
3/30/98 |
Guidance
for Industry: Guidance for Human Somatic Cell Therapy
and Gene Therapy FDA199803A
Previous
& Complementary Versions:
|
30 |
|
3/20/98 |
Guidance
for Industry: Supplemental Testing and the Notification
of Consignees of Donor Test Results for Antibody to Hepatitis
C Virus (Anti-HCV) FDA199803B |
8 |
|
3/18/98 |
Guidance
for Industry: Clinical Development Programs for Drugs,
Devices and Biological Products for the Treatment of Rheumatoid
Arthritis (RA) (DRAFT) FDA199803C
Previous
Version:
Draft 1/6/97 FDA199701B |
|
|
52 |
|
2/12/98 |
Guidance
for Industry: Clinical Development Programs for Drugs,
Devices, and Biological Products Intended for the Treatment
of Osteoarthritis (OA) FDA199802B |
8 |
|
2/98 |
Implementation
of Section 126, Elimination of Certain Labeling Requirements,
of the Food and Drug Administration Modernization Act
of 1997 FDA199802A |
3 |
|
1/28/98 |
Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol
for Sterile Products (DRAFT) FDA199801A |
8 |
|
1/26/98 |
Efficacy Studies to Support Marketing of Fibrin Sealant
Products Manufactured for Commercial Use (DRAFT) FDA199801B |
5 |
|
1/20/98 |
Request
for Proposed Standards for Unrelated Allogeneic Peripheral
and Placental/Umbilical Cord Blood Hematopoietic Stem/Progenitor
Cell Products (Federal Register Document - Notice) FDA199801Efr |
4 |
|
1/5/98 |
Aluminum
in Large and Small Volume Parenterals Used in Total Parenteral
(Federal Register Document - Proposed Rule) FDA199801Dfr) |
10 |
|
1/5/98 |
Commercialization
of In Vitro Diagnostic Devices (IVD’s) Labeled for
Research Use Only or Investigational Use Only (Federal
Register Document - Availability Notice) FDA199801Cfr) |
2 |
|
| Date
Issued |
Title |
Pages |
Doc
(.pdf) |
| 12/29/97 |
Guidance For the Submission of Chemistry, Manufacturing
and Controls and Establishment Description Information
for Human Plasma-Derived Biological Products or Animal
Plasma or Serum-Derived Products (DRAFT) FDA199712A) |
19 |
|
| 12/24/97 |
Guidance
for Industry: Q3C Impurities: Residual Solvents |
16 |
|
| 12/9/97 |
Establishment
of Prescription Drug User Fee Rates for Fiscal Year 1998
(Federal Register Document - Notice) FDA199712Cfr) |
3 |
|
| 12/3/97 |
Industry-Supported Scientific and Educational Activities
(Federal Register Document - Final Notice) FDA199712Bfr) |
28 |
|
| 11/97 |
Environmental Assessment of Human Drug and Biologics
Applications (DRAFT) FDA199711A) |
45 |
|
| 10/31/97 |
Recombinant
DNA Research: Actions Under the Guidelines (Federal Register
Document - Notice) FDA199710Dfr |
16 |
|
| 10/15/97 |
Revision
of the Requirements for a Responsible Head for Biological
Establishments (Federal Register Document - Final Rule) FDA199710Cfr |
3 |
|
| 10/7/97 |
Expedited
Safety Reporting Requirements for Human Drug and Biological
Products (Federal Register Document - Final Rule) FDA199710Bfr |
17 |
|
| 10/97 |
The
Sourcing and Processing of Gelatin to Reduce the Potential
Risk Posed by Bovine Spongiform Encephalopathy (BSE) in
FDA-Regulated Products for Human Use FDA199710F |
16 |
(.htm) |
| 10/97 |
PDUFA Reauthorization Performance Goals and Procedures FDA199710E |
12 |
|
| 10/97 |
Team
Biologics: A Plan for Reinventing FDA’s Ability to
Optimize Compliance of Regulated Biologics Industries FDA199710A) |
14 |
|
| 9/24/97 |
Investigational
New Drug Applications; Proposed Amendment to Clinical
Hold Regulations for Products Intended for Life-Threatening
Diseases (Federal Register Document - Proposed Rule) FDA199709Bfr |
9 |
|
| 9/23/97 |
Biological
Products; Reporting of Errors and Accidents in Manufacturing
(Federal Register Document - Proposed Rule) FDA199709Afr |
7 |
|
| 8/27/97 |
Postmarketing
Adverse Experience Reporting for Human Drug and Licensed
Biological Products: Clarification of What to Report FDA199708A |
6 |
|
| 8/25/97 |
Testing
Limits in Stability Protocols for Standardized Grass Pollen
Extracts (DRAFT) FDA199708C |
10 |
|
| 8/15/97 |
Regulations
Requiring Manufacturers to Assess the Safety and Effectiveness
of New Drugs and Biological Products in Pediatric Patients
(Federal Register Document - Proposed Rule) FDA199708Bfr |
18 |
|
| 8/15/97 |
Donor
Screening for Antibodies to HTLV-II FDA199708D |
9 |
|
| 7/31/97 |
Accessibility
To New Drugs for Use in Military and Civilian Exigencies
when Traditional Human Efficacy Studies are Not Feasible;
Determination Under the Interim Rule that Informed Consent
is Not Feasible for Military Exigencies (Federal Register
Document - Request for Comments) FDA199707Efr |
6 |
|
| 7/29/97 |
Screening
and Testing of Donors of Human Tissue Intended for Transplantation FDA199707C) |
13 |
|
| 7/24/97 |
Changes
to an Approved Application: Biological Products FDA199707B) |
13 |
|
| 7/24/97 |
Changes
to an Approved Application for Specified Biotechnology
and Specified Synthetic Biological Products FDA199707A) |
10 |
|
| 7/11/97 |
General
Services Administration: Final Record of Decision
(regarding new consolidated, state-of-the-art facilities
for FDA in Montgomery County, MD) (Federal Register Document
- Notice) FDA199707Ffr |
8 |
|
| 7/8/97 |
Revised
Form FDA 356h, Application to market a New Drug, Biologic,
or an Antibiotic Drug for Human Use; Availability (Federal
Register Document - Notice) FDA199707Gfr |
3 |
|
| 7/97 |
Consumer-Directed
Broadcast Advertisements (DRAFT) FDA199707D) |
4 |
|
| 6/18/97 |
Computerized
Systems Used in Clinical Trials FDA199706B) |
14 |
|
| 6/97 |
Guidance
for the Submission of Documentation in Drug Applications
for Container Closure Systems Used for the Packaging of
Human Drugs and Biologics FDA199706A) |
61 |
|
| 5/16/97 |
International
Conference on Harmonisation (ICH) Guidelines for the Photostability
Testing of New Drug Substances and Products |
8 |
|
| 4/10/97 |
Evaluation
of Combination Vaccines for Preventable Diseases: Production,
Testing and Clinical Studies FDA199704A |
24 |
|
| 3/13/97 |
Providing Clinical Evidence of Effectiveness for Human
Drug and Biological Products (DRAFT) FDA199703B |
20 |
|
| 3/13/97 |
FDA Approval of New Cancer Treatment Uses for Marketed
Drug and Biological Products (DRAFT)(FDA199703A) |
10 |
|
| 3/11/97 |
Design
Control Guidance for Medical Device Manufacturers FDA199703C) |
52 |
|
| 2/28/97 |
Points
to Consider in the Manufacture and Testing of Monoclonal
Antibody Products for Human Use FDA199702A |
47 |
|
| 2/28/97 |
Proposed
Approach to Regulation of Cellular and Tissue-Based Products FDA199702C |
31 |
|
| 2/27/97 |
The
Food and Drug Administration’s Development, Issuance
and Use of Guidance Documents (Federal Register Document
- Notice) FDA199702Dfr |
12 |
|
| 2/97 |
Reinventing
the Regulation of Human Tissue FDA199702B |
16 |
(html)
(pdf) |
| 1/29/97 |
Revision
of the Requirements for a Responsible Head for Biological
Establishments (Federal Register Document - Proposed Rule) FDA199701Cfr |
3 |
|
| 1/10/97 |
Guidance for the Submission of Chemistry, Manufacturing,
and Controls Information and Establishment Description
for Autologous Somatic Cell Therapy Products FDA199701A |
19 |
|
| 1/6/97 |
Clinical Development Programs for Drugs, Devices, and
Biological Products for the Treatment of Rheumatoid Arthritis
(RA) (DRAFT) FDA199701B |
51 |
|
| Date
Issued |
Title |
Pages |
Doc
(.pdf) |
| 12/26/96 |
USDA
(Animal and Plant Health Inspection Service): Viruses,
Serums, Toxins, and Analogous Products: Encephalomyelitis
Vaccine, Eastern, Western, and Venezuelan, Killed Virus
(Federal Register Document - Final Rule) FDA199612Bfr |
2 |
|
| 12/22/96 |
|
35 |
|
| 12/19/96 |
Current
Good Manufacturing Practices for Blood and Blood Components:
Notification of Consignees Receiving Blood and Blood Components
at Increased Risk for Transmitting HIV Infection; Correction
of Effective Date (Federal Register Document - Final Rule;
correction of effective date) FDA199612Cfr |
1 |
|
| 11/96 |
International
Conference on Harmonisation (ICH); Guidance for Industry:
E2C Clinical Safety Data Management: Periodic Safety Update
Reports for Marketed Drugs |
24 |
|
| 11/22/96 |
NIH:
Recombinant DNA Research: Proposed Actions Under
the Guidelines (Federal Register Document - Notice) FDA199611Dfr |
18 |
|
| 11/6/96 |
Prominence
of Name of Distributor of Biological Products (Federal
Register Document - Final Rule) FDA199911Cfr |
3 |
|
| 11/4/96 |
Electronic
Submission of Case Report Forms and Case Report Tabulations
(DRAFT) FDA199611B |
12 |
|
| 11/4/96 |
|
7 |
|
| 9/23/96 |
|
14 |
|
| 9/20/96 |
Guidance
for Industry: Manufacture, Processing or Holding of Active
Pharmaceutical Ingredients (DRAFT) FDA199609A |
63 |
|
| 8/15/96 |
Guidance
for Industry: Submission of Chemistry, Manufacturing,
and Controls Information for a Therapeutic Recombinant
DNA-Derived Product or a Monoclonal Antibody Product for
In Vivo Use FDA199608A |
30 |
|
| 7/10/96 |
Q5C
International Conference on Harmonisation: Final Guidance
on Stability Testing of Biotechnological / Biological
Products |
5 |
|
| 5/24/96 |
Guidance
on Applications for Products Comprised of Living Autologous
Cells Manipulated Ex Vivo and Intended for Structural
Repair or Reconstruction FDA199605B |
9 |
|
| 5/14/96 |
Elimination
of Establishment License Application for Specified Biotechnology
and Specified Synthetic Biological Products (Federal Register
Document - Final Rule) FDA199605Afr |
7 |
|
| 5/3/96 |
Current
Good Manufacturing Practice: Amendment of Certain
Requirements for Finished Pharmaceuticals (Federal Register
Document - Proposed Rule) FDA199605Cfr |
13 |
|
| 4/26/96 |
FDA
Guidance Concerning Demonstration of Comparability of
Human Biological Products, Including Therapeutic Biotechnology-Derived
Products FDA199604A |
16 |
|
| 3/96 |
S1A
International Conference on Harmonisation: Final Guideline
on the Need for Long-Term Rodent Carcinogenicity Studies
of Pharmaceuticals |
4 |
|
| 3/1/96 |
Computer
Assisted Product License Application -CAPLA- Guidance
Manual FDA199603A |
86 |
|
| 2/96 |
International
Conference on Harmonisation: Final Guideline on Quality
of Biotechnical Products: Analysis of the Expression Construct
in Cells Used for the Production of r-DNA Derived Protein
Products - 2/1996 - |
2 |
|
| 1/29/96 |
Well
Characterized Biotechnology Products; Elimination of Establishment
License Applications (Federal Register Document - Proposed
Rule) FDA199601Dfr |
7 |
|
| 1/29/96 |
Changes
to an Approved Application; Draft Guidance (Federal Register
Document - Proposed Rule) FDA199601Bfr |
10 |
|
| 1/29/96 |
Changes
to An Approved Application for a Well-Characterized Therapeutic
Recombinant DNA-Derived and Monoclonal Antibody Biotechnology
Product (Federal Register Document - Proposed Rule, Availability) FDA199601Cfr |
2 |
|
| 1/2/96 |
|
18 |
|
| Date
Issued |
Title |
Pages |
Doc
(.pdf) |
| 12/95 |
Draft
Document Concerning the Regulation of Placental/Umbilical
Cord Blood Stem Cell Products Intended for Transplantation
or Further Manufacturing into Injectable Products FDA199512A |
18 |
|
| 12/8/95 |
Interim
Definition and Elimination of Lot-by-Lot Release for Well-Characterized
Therapeutic Recombinant DNA-Derived and Monoclonal Antibody
Biotechnology Products (Federal Register Document - Notice) FDA199512Bfr |
2 |
|
| 11/95 |
Guidance
for Industry: Immediate Release Solid Oral Dosage Forms;
Scale-Up and Post approval Changes: Chemistry, Manufacturing,
and Controls, In Vitro Dissolution Testing, and In Vivo
Bioequivalence Documentation FDA199511C |
30 |
|
| 11/95 |
Guidance
for Industry for the Submission of an Environmental Assessment
in Human Drug Applications and Supplements FDA199511B |
47 |
|
| 11/1/95 |
Content
and Format of Investigational New Drug Applications (INDs)
for Phase 1 Studies of Drugs, Including Well-Characterized,
Therapeutic, Biotechnology-derived Products FDA199511A |
17 |
|
| 10/3/95 |
Points
to Consider for the Evaluation of Combination Vaccines:
Production, Testing and Clinical Study FDA199510A |
28 |
|
| 8/22/95 |
Points
to Consider in the Manufacture and Testing of Therapeutic
Products for Human Use Derived from Transgenic Animals FDA199508A |
20 |
|
| 7/11/95 |
FDA
Guidance Document Concerning Use of Pilot Manufacturing
Facilities for the Development and Manufacture of Biological
Products; Availability (Federal Register Document - Notice) FDA199507Afr |
4 |
|
| 6/26/95 |
FDA
Guidance Document Concerning Use of Pilot Manufacturing
Facilities for the Development and Manufacture of Biological
Products; Availability FDA199506A |
11 |
|
| 4/6/95 |
Changes
to be Reported for Product and Establishment Applications;
Guidance FDA199504A |
13 |
|
| 4/6/95 |
Changes
to be Reported for Product and Establishment Applications;
Guidance (Federal Register Document - Notice) FDA199504Afr |
4 |
|
| 1995 |
Draft
Guide to Preparing Form 3210: Application for Establishment
License for Manufacture of Biological Products FDA199500B |
32 |
|
| 1995 |
CBER
Manual of Managed Review Process FDA199500A |
71 |
|
