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Generic Drug Guidances
180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (PDF - 138KB)
Final Guidance, (07/01/03)
Controlled Correspondence Related to Generic Drug Development (PDF - 379KB)
Final Guidance, (09/28/15)
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. (PDF - 25KB)
Final Guidance, (03/01/00)
Handling and Retention of Bioavailability and Bioequivalence Testing Samples (PDF - 190KB)
Final Guidance, (05/25/04)
Individual Product Bioequivalence Recommendations for Specific Products (PDF - 80KB)
Final Guidance, (06/10/10)
Letter describing efforts by the CDER and the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new and abbreviated drug approval process in order to reduce duplication or redundancy in the process (PDF - 274KB)
Final Guidance, (10/01/94)
Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy (PDF - 1.9MB)
Final Guidance, (09/01/94)
Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters (PDF - 254KB)
Final Guidance, (07/01/92)
Letter on the provision of new procedures and policies affecting the generic drug review process (PDF - 608KB)
Final Guidance, (03/01/89)
Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions (PDF - 917KB)
Final Guidance, (11/01/90)
Letter on the response to 12/20/1984 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act (PDF - 392KB)
Final Guidance, (03/01/85)
Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse-to-file incomplete submissions as required by the new law (PDF - 233KB)
Final Guidance, (01/01/93)
Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements (PDF - 908KB)
Final Guidance, (08/01/93)
Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications (PDF - 34KB)
Final Guidance, (12/01/01)
Revising ANDA Labeling Following Revision of the RLD Labeling (PDF - 19KB)
Final Guidance, (04/26/00)
Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (PDF - 137KB)
Final Guidance, (05/05/11)
Variations in Drug Products that May Be Included in a Single ANDA (PDF - 107KB)
Final Guidance, (12/01/98)
Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1) (PDF - 244KB)
Draft Guidance, (09/10/13)
ANDA Submissions -- Refuse-to-Receive Standards (PDF - 206KB)
Final Guidance, (05/26/15)
ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 214KB)
Draft Guidance, (06/11/14)
ANDA Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA (PDF - 231KB)
Draft Guidance, (07/10/14)
ANDA Submissions – Prior Approval Supplements Under GDUFA (PDF - 173KB)
Draft Guidance, (07/10/14)
ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits (PDF - 326KB)
Final Guidance, (08/24/16)
How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD (PDF - 72KB)
Draft Guidance, (12/04/14)
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry (PDF - 53KB)
Draft Guidance, (10/05/15)
Pharmaceutical Quality/CMC
Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry (PDF - 432KB)
Final Guidance, (02/12/16)
General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry (PDF - 2.3MB)
Draft Guidance, (03/24/16)
Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry (PDF - 189KB)
Draft Guidance, (05/31/16)
Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry (PDF - 94KB)
Draft Guidance, (07/08/16)
Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry (PDF - 268KB)
Final Guidance, (09/22/16)
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MD. Saddam Nawaz
INTRO
DISCLAIMER
CONSULT EXPERTISE
PROJECT MANAGEMENT
COMMISSIONING, QUALIFICATION & VALIDATION
QUALITY MANAGEMENT SYSTEMS
REGULATORY COMPLIANCE
GMP DISCUSSION
GMP INSIGHTS
BLOG
SME VOICE
ABOUT GMP
WHAT IS GMP?
GUIDELINES SOURCES
USFDA TOPIC GUIDANCES
>
CDER
CBER
GENERICS
BIOPHARMACEUTICS
GMP INSPECTIONS
483 AND WARNING LETTERS
GMP GLOSSARY
A
B
C
D
E
F
G
H
I
K
L
M
N
O
P
Q
R
S
T
U
V
W, Y & Z