Date
Issued |
Title |
Pages |
Doc
(.pdf) |
9/17/08 |
International Conference on Harmonisation: (ICH); Guidance for Industry: S1C(R2) Dose Selection for Carcinogenicity Studies |
13 |
 |
9/9/08 |
Concept Paper: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule |
17 |
|
9/8/08 |
Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases |
11 |
|
9/4/08 |
M3(R2) Nonclinical Safety Studies
for the Conduct of
Human Clinical Trials and
Marketing Authorization for Pharmaceuticals |
28 |
|
8/27/08 |
Draft Guidance for Industry on Integrated Summary of Effectiveness |
16 |
|
8/07/08 |
Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff: Humanitarian Device Exemption (HDE) Regulation: Questions and Answers |
23 |
|
8/07/08 |
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees |
25 |
|
8/07/08 |
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers |
14 |
|
8/07/08 |
Guidance for FDA Advisory Committee Members and FDA Staff: Voting Procedures for Advisory Committee Meetings |
6 |
|
8/07/08 |
Guidance for Industry: Advisory Committee Meetings - Preparation and Public Availability of Information Given to Advisory Committee Members |
20 |
|
8/07/08 |
Draft Guidance for the Public and FDA Staff: Convening Advisory Committee Meetings |
6 |
|
8/07/08 |
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter |
4 |
|
8/07/08 |
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter |
4 |
|
8/07/08 |
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter |
4 |
|
8/07/08 |
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 5: Disintegration Test General Chapter |
6 |
|
8/05/08 |
International Conference on Harmonisation (ICH); Draft Guideline: E2F Development Safety Update Report |
34 |
|
8/05/08 |
Draft Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes |
9 |
|
7/30/08 |
Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products |
7 |
|
7/29/08 |
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions -Statement of Investigator (Form FDA 1572) |
13 |
|
07/17/08 |
Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency |
17 |
|
07/15/08 |
CGMP for Phase 1 Investigational Drugs
Current Good Manufacturing Practice
and Investigational New Drugs
Intended for Use in Clinical Trials (21 CFR Part 210) |
20
11 |
|
6/17/08 |
Guidance for Industry: Indexing Structured Product Labeling (Revision 1) |
9 |
|
06/11/08 |
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Postmarketing Individual Case Safety Reports |
11 |
|
06/11/08 |
Providing Regulatory Submissions in Electronic Format - Postmarketing Individual Case Safety Reports |
11 |
|
06/05/08 |
International Conference on Harmonisation (ICH); Guidance for Industry: Q3A Impurities in New Drug Substances |
17 |
|
05/30/08 |
Guidance for Industry: Indexing Structured Product Labeling |
9 |
|
05/21/08 |
Draft Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products |
14 |
|
5/20/08 |
Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) |
10 |
|
04/28/08 |
Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application |
17 |
|
04/25/08 |
Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) |
14 |
|
04/21/08 |
Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007 |
4 |
|
04/16/08 |
Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests |
10 |
|
04/09/08 |
Guidance
for FDA Reviewers and Sponsors: Content and Review of
Chemistry, Manufacturing, and Control (CMC) Information
for Human Somatic Cell Therapy Investigational New Drug
Applications (INDs) |
39 |
|
04/09/08 |
Guidance
for FDA Reviewers and Sponsors: Content and Review of
Chemistry, Manufacturing, and Control (CMC) Information
for Human Gene Therapy Investigational New Drug Applications
(INDs) |
44 |
|
04/07/08 |
International
Conference on Harmonisation (ICH); Guidance for Industry:
E15 Definitions for Genomic Biomarkers, Pharmacogenomics,
Pharmacogenetics, Genomic Data and Sample Coding Categories |
10 |
|
03/25/2008 |
S2(R1)
Genotoxicity Testing and Data Interpretation for Pharmaceuticals
Intended for Human Use |
38 |
|
03/07/08 |
Guidance
for Industry and FDA Staff: Interactive Review for Medical
Device Submissions: 510(k)s, Original PMAs, PMA Supplements,
Original BLAs, and BLA Supplements |
14 |
|
03/07/08 |
Guidance
for Industry and FDA Staff: Expedited Review of Premarket
Submissions for Devices |
15 |
|
02/22/08 |
Guidance
for Industry: Container and Closure System Integrity
Testing in Lieu of Sterility Testing as a Component
of the Stability Protocol for Sterile Products |
9 |
|
2/21/08 |
ICHQ4B
Evaluation and Recommendation of Pharmacopoeial Texts
for Use in the ICH Regions (8/6/07)
Annex
1: Residue on Ignition/Sulphated Ash General Chapter
Analytical Procedures and/or Acceptance Criteria (APAC)
(8/7/06) |
14
6 |
|
2/11/08 |
Draft
Guidance for Industry: Validation of Growth-Based Rapid
Microbiological Methods for Sterility Testing of Cellular
and Gene Therapy Products |
14 |
|
01/10/08 |
International
Conference on Harmonisation (ICH); Draft Guidance:
Q8(R1) Pharmaceutical Development Revision 1
- ICH
Q8 Pharmaceutical Development (5/19/06)
|
16 |
|
01/11/08 |
FDA
Licenses 14 New Blood-Typing Tests
New tests help assure safe transfusions |
1 |
|
Date
Issued |
Title |
Pages |
Doc
(.pdf) |
12/31/07 |
Guidance
for Industry and FDA Staff: Interactive Review for Medical
Device Submissions: 510(k)s, Original PMAs, PMA Supplements,
Original BLAs, and BLA Supplements |
14 |
|
12/17/07 |
Guidance
for Industry and FDA Review Staff: Collection of Platelets
by Automated Methods |
34 |
|
12/14/07 |
Draft
ICH Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions
Annex
2: Test for Extractable Volume of Parenteral Preparations
General Chapter
Annex
3: Test for Particulate Contamination: Subvisible
Particles General Chapter |
4
7
|
|
11/29/07 |
Guidance
for Industry and FDA Staff: Class II Special Controls
Guidance Document: Automated Blood Cell Separator Device
Operating by Centrifugal or Filtration Separation Principle |
8 |
|
11/27/07 |
Guidance
for Industry: Providing Regulatory Submissions to the
Center for Biologics Evaluation and Research (CBER)
in Electronic Format - Lot Release Protocols |
8 |
|
11/21/07 |
Guidance
for Industry: Adequate and Appropriate Donor Screening
Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAG)
Assays Used to Test Donors of Whole Blood and Blood
Components, Including Source Plasma and Source Leukocytes |
6 |
|
11/1/07 |
Draft
Guidance for the Public, FDA Advisory Committee and
FDA Staff: Public Availability of Advisory Committee
Members' Financial Interest Information Waivers |
12 |
|
10/29/07 |
Draft
Guidance for Industry and FDA Staff: Invitro Diagnostic
(IVD) Device Studies - Frequently Asked Questions |
49 |
|
10/29/07 |
Guidance
for Industry: Considerations for Plasmid DNA Vaccines
for Infectious Disease Indications |
13 |
|
10/26/07 |
Guidance
for Industry: Blood Establishment Computer System Validation
in User's Facility |
11 |
|
10/24/07 |
Guidance
for Industry: Drug Induced Liver Damage - Premarketing
Clinical Evaluation |
26 |
|
10/24/07 |
Guidance
for Industry, FDA and Foreign Governments: FY 2008 Medical
Device User Fee Small Business Qualification and Certification |
34 |
|
10/18/07 |
Federal
Register/Vol. 72, No. 201 / Rules and Regulations |
4 |
|
10/18/07 |
Federal
Register/Vol. 72, No. 201 / Proposed Rules |
4 |
|
9/27/07 |
Guidance
for Industry: Toxicity Grading Scale for Healthy Adult
and Adolescent Volunteers Enrolled in Preventive Vaccine
Clinical Trials |
10 |
|
9/14/07 |
Guidance
for Industry and FDA Staff: Commercially Distributed
Analyte Specific Reagents (ASRs): Frequently Asked Questions |
13 |
|
9/6/07 |
Guidance
for Industry: Manufacturing Biological Intermediates
and Biological Drug Substances Using Spore-Forming Microorganisms |
17 |
|
8/28/07 |
Draft
Guidance for Industry: Pharmacogenomic Data Submissions
- Companion Guidance |
28 |
|
8/24/07 |
Guidance
for Industry: Pharmacogenomic Data Submissions - Companion
Guidance |
28 |
|
8/24/07 |
Guidance
for Industry: Regulation of Human Cells, Tissues and
Cellular and Tissue Based Products (HCTP/s) Small Entity
Compliance Guide |
15 |
|
8/24/07 |
Guidance
for Industry: "Lookback" for Hepatitis C Virus
(HCV): Product Quarantine, Consignee Notification, Further
Testing, Product Disposition and Notification of Transfusion
Recipients Based on Donor Test Results Indicating Infection
with HCV |
20 |
|
8/8/07 |
Guidance
for Industry: Class II Special Controls Guidance Document:
In Vitro HIV Drug Resistance Genotype Assay |
29 |
|
8/7/07 |
Guidance
for Industry: Adequate and Appropriate Donor Screening
Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAG)
Assays Used to Test Donors of Whole Blood and Blood
Components, Including Source Plasma and Source Leukocytes |
6 |
|
7/31/07 |
Guidance:
Emergency Use Authorization of Medical Products |
16 |
|
7/24/07 |
Guidance
for Industry: Exports under the FDA Export Reform and
Enhancement Act of 1996 |
61 |
|
7/24/07 |
Draft
Guidance for Industry, Clinical Laboratories, and FDA
Staff: In Vitro Diagnostic Multivariate Index Assays |
15 |
|
7/23/07 |
Draft
Guidance for Industry: Cell Selection Devices for Point
of Care Production of Minimally Manipulated Autologous
Peripheral Blood Stem Cells (PBSCs) |
7 |
|
7/23/07 |
Federal
Register Vol.72, No.140/ Notices |
3 |
|
7/20/07 |
Draft
Guidance for Industry: Cooperative Manufacturing Arrangements
for Licensed Biologics |
17 |
|
7/12/07 |
International
Conference on Harmonisation (ICH); Draft Guidance: Q10
Pharmaceutical Quality System |
19 |
|
7/6/07 |
Draft
Guidance for Industry: Preparation of IDEs and INDs
for Products Intended to Repair or Replace Knee Cartilage |
19 |
|
7/2/07 |
Draft
Guidance for Industry: Integrated Summaries of Effectiveness
and Safety: Location Within the Common Technical Document |
10 |
|
6/22/07 |
Guidance
for Industry and FDA Staff: Bundling Multiple Devices
or Multiple Indications in a Single Submission |
17 |
|
6/20/07 |
Guidance
for Industry: Informed Consent Recommendations for Source
Plasma Donors Participating in Plasmapheresis and Immunization
Programs |
9 |
|
6/20/07 |
Draft
Guidance for Industry: "Computer Crossmatch"
(Electronic Based Testing for the Compatability between
the Donor's Cell Type and the Recipient's Serum or Plasma
Type) |
14 |
|
6/4/07 |
Draft
Guidance for Industry: Providing Regulatory Submissions
in Electronic Format - Receipt Date |
9 |
|
5/31/07 |
Guidance
for Industry: Clinical Data Needed to Support the Licensure
of Pandemic Influenza Vaccines |
20 |
|
5/31/07 |
Guidance
for Industry: Clinical Data Needed to Support the Licensure
of Seasonal Inactivated Influenza Vaccines |
17 |
|
5/15/07 |
Guidance
for Industry: Clinical Trial Endpoints for the Approval
of Cancer Drugs and Biologics |
22 |
|
5/10/07 |
Guidance
for Industry: Computerized Systems Used in Clinical
Investigations |
13 |
|
5/10/07 |
Draft
Guidance for Industry: Protecting the Rights, Safety
and Welfare of Study Subjects - Supervisory Responsibility
of Investigators |
19 |
|
4/17/07 |
Draft
Guidance for Clinical Investigators, Sponsors and IRBs
Adverse Event Reporting - Improving Human Subject Protections |
11 |
|
4/9/07 |
Draft
Guidance for Industry: Dosage and Administration Section
of Labeling for Human Presciption Drug and Biological
Products - Content and Format |
13 |
|
3/26/07 |
Draft
Guidance for Industry and FDA Staff: Modifications to
Devices Subject to Pre Market Approval (PMA) - The PMA
Supplement Decision Making Process |
32 |
|
2/27/07 |
Guidance
for Industry: Advisory Committee Meetings - Preparation
and Public Availability of Information Given to Advisory
Committee Members |
19 |
|
2/27/07 |
Draft
Guidance for Industry: Complimentary and Alternative
Medicine Products and Their Regulation by the Food and
Drug Administration |
17 |
|
| |
Comment
to the Docket on the "Draft Guidance for Industry:
Complementary and Alternative Medicine Products and
their Regulation by the Food and Drug Administration |
1 |
|
2/27/07 |
Guidance
for Industry: Eligibility Determination for Donors of
Human Cells,Tissues, and Cellular and Tissue Based Products
(HCT/Ps) |
71 |
|
1/31/07 |
Guidance
for Industry: Class II Special Controls Guidance Document:
Cord Blood Processing System and Storage Container |
19 |
|
1/23/07 |
Guidance
for Industry: Certain Human Cells, Tissues, and Cellular
and Tissue Based Products (HCT/Ps) Recovered from Donors
Who Were Tested for Communicable Diseases Using Pooled
Specimens or Diagnostic Tests |
10 |
|
1/16/07 |
Draft
Guidance for Industry: Minimally Manipulated, Unrelated
Allogeneic Placental/Umbilical Cord Blood Intended for
Hematopoietic Reconstitution in Patients with Hematological
Malignancies |
49 |
|
1/8/07 |
ICH
Draft Guidance E15 Terminology in Pharmacogenomics |
8 |
|
Date
Issued |
Title |
Pages |
Doc
(.pdf) |
11/28/06 |
Guidance
for Industry: Gene Therapy Clinical Trials - Observing
Subjects for Delayed Adverse Events |
25 |
|
11/28/06 |
Guidance
for Industry: 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 |
15 |
|
10/27/06 |
Guidance
for Industry: Implementation of Acceptable Full Length
Donor History Questionnaire and Accompanying Materials
for Use in Screening Donors of Blood and Blood Components |
10 |
|
10/30/06 |
Guidance
for Industry: Investigating Out-of-Specification (OOS)
Test Results for Pharmaceutical Production |
17 |
|
10/18/06 |
Guidance
for Industry: Biological Product Deviation Reporting
for Licensed Manufacturers of Biological Products Other
than Blood and Blood Components |
20 |
|
10/18/06 |
Guidance
for Industry: Biological Product Deviation Report for
Blood and Plasma Establishments |
32 |
|
10/5/06 |
Guidance
for Industry: Bar Code Label Requirements - Questions
and Answers |
13 |
|
9/29/06 |
Federal
Register /Vol.71, No. 189/ September 29, 2006/ Notices |
2 |
|
9/29/06 |
Guidance
for Industry: Quality Systems Approach to Pharmaceutical
CGMP Regulations |
32 |
|
9/28/06 |
ICH
E5 Ethnic Factors: Questions and Answers |
10 |
|
9/28/06 |
Guidance
for Industry: Characterization and Qualification of
Cell Substrates and Other Biological Starting Materials
Used in the Production of Viral Vaccines for the Prevention
and Treatment of Infectious Diseases |
52 |
|
9/22/06 |
Guidance
for Industry: Recognition and Use of a Standard for
Uniform Blood and Blood Component Container Labels |
5 |
|
9/22/06 |
United
States Industry Consensus Standard for the Uniform Labeling
of Blood and Blood Components Using ISBT 128 |
90 |
|
9/11/06 |
Guidance
for Industry: Drug Interaction Studies - Study Design,
Data Analysis, and Implications for Dosing and Labeling |
55 |
|
9/8/06 |
Guidance
for Industry: Compliance with 21 CFR Part 1271.150(c)(1)
- Manufacturing Arrangements |
5 |
|
9/7/06 |
Draft
Guidance for Institutional Review Boards, Clinical Investigators,
and Sponsors - Exception from Informed Consent Requirements
for Emergency Research |
30 |
|
9/2/06 |
Guidance
for Industry and FDA Staff: Minimal Manipulation of
Structural Tissue Jurisdictional Update |
7 |
|
9/1/06 |
Federal
Register - Annual Guidance Agenda |
12 |
|
8/29/06 |
Federal
Register: Requirements for Foreign an Domestic Establishment
Registration and Listing for Human Drugs, Including
Drugs that are Regulated Under a Biologics License Application,
and Animal Drugs; Proposed Rule |
83 |
|
8/8/06 |
Guidance
for Industry: Amendment (Donor Deferal for Transfuion
in France Since 1980) to "Guidance for Industry:
Revised Preventative Measures to Reduce the Possible
Risk of Transmission of Creutzfeldt-Jacob Disease (CJD)
and Variant Creutzfeldt-Jacob Disease (vCJD) by Blood
and Blood Products" |
6 |
|
8/8/06 |
Guidance
for Industry: Implementing a Collection Program for
Source Plasma Containing Disease-Associated and Other
Immunoglobulin G(IgG) |
6 |
|
8/7/06 |
ICHQ4B
Draft Guidance: Regulatory Acceptance of Analytical
Procedures and/or Acceptance Criteria (RAAPAC) |
7 |
|
8/7/06 |
ICHQ4B
Draft Guidance: Regulatory Acceptance of Analytical
Procedures and/or Acceptance Criteria (RAAPAC)
Annex
1: Residue on Ignition/Sulphated Ash General Chapter
Analytical Procedures and/or Acceptance Criteria (APAC) |
4 |
|
7/06 |
ICH
Q3B(R2) Impurities in New Drug Products |
18 |
|
6/12/06 |
Guidance
for Industry: Providing Regulatory Submissions to the
Center for Biologics Evaluation (CBER) in Electronic
Format - Lot Release Protocols |
9 |
|
6/1/06 |
Guidance
for Industry: Chronic Cutaneous Ulcer and Burn Wounds
- Developing Products for Treatment |
22 |
|
6/1/06 |
ICH
Q9 Quality Risk Management |
25 |
|
5/19/06 |
ICH
Q8 Pharmaceutical Development |
12 |
|
5/4/06 |
Guidance
for Industry: Development of Preventative HIV Vaccines
for Use in Pediatric Populations |
9 |
|
4/27/06 |
Guidance
for Industry: Bar Code Label Requirements - Questions
and Answers |
11 |
|
4/25/06 |
Guidance
for Sponsors, Institutional Review Boards, Clinical
Investigators and FDA Staff: Guidance on Informed Consent
for In Vitro Diagnostic Device Studies Using Leftover
Human Specimans that are not Individually Identifiable |
10 |
|
4/25/06 |
Draft
Guidance for Industry: Informed Consent Recommendations
for Source Plasma Donors Participating in Plasmapheresis
and Immunization Programs |
9 |
|
4/19/06 |
Guidance
for Industry: Providing Regulatory Submissions in Electronic
Format - Human Pharmaceutical Product Applications and
Related Submissions Using the eCTD Specifications |
20 |
|
ICH
4/12/06 |
Guidance
for Industry: S8 Immunotoxicity Studies for Human Pharmaceuticals |
16 |
|
3/28/06 |
Federal
Register: Annual Comprehensive List of Guidance Documents
at the Food and Drug Administration |
46 |
|
3/27/06 |
Guidance
for Clinical Trial Sponsors: Establishment and Operation
of Clinical Trial Data Monitoring Committees |
38 |
|
3/15/06 |
Guidance
for Industry: Using a Centralizled IRB Review Process
in Multicenter Clinical Trials |
10 |
|
3/2/06 |
Draft
Guidance for Industry: Clinical Data Needed to Support
the Licensure of Pandemic Infuenza Vaccines |
17 |
|
3/2/06 |
Draft
Guidance for Industry: Clinical Data Needed to Support
the Licensure of Trivalent Inactivated Influenza Vaccines |
14 |
|
2/15/06 |
Guidance
for Industry: Reports on the Status of Postmarketing
Study Commitments - Implementation of Section 130 of
the Food and Drug Administration Modernization of 1997 |
25 |
|
2/13/06 |
Guidance
for Industry: Considerations for Developmental Toxicity
Studies for Preventive and Therapeutic Vaccines for
Infectious Disease Indications |
14 |
|
2/2/06 |
Guidance
for Industry: Patient Reported Outcome Measures: Use
in Medical Product Development to Support Labeling Claims |
36 |
|
1/06 |
Guidance
for Industry, Investigators, and Reviewers
Exploratory
IND Studies |
16 |
|
1/18/06 |
Guidance
for Industry: Labeling for Human Prescription Drug and
Biological Products - Implementing the New Content and
Format Requirements |
31 |
|
1/18/06 |
Guidance
for Industry: Warning and Precautions Contraindications
and Boxed Warning Sections of Labeling for Human Prescription
Drug and Biological Products - Content and Format |
14 |
|
1/18/06 |
Guidance
for Industry: Clinical Studies Section of Labeling for
Human Prescription Drug and Biological Products - Content
and Format |
25 |
|
1/18/06 |
Guidance
for Industry: Adverse Reactions Section of Labeling
for Human Prescription Drug and Biological Produt -
Content and Format |
16 |
|
1/12/06 |
Draft
Guidance for Industry: INDs - Approaches to Complying
with cGMP During Phase 1 |
20 |
|
