Generics |
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence |
Draft |
10/21/2022 |
Generics |
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs |
Draft |
10/21/2022 |
Generics |
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs |
Draft |
10/21/2022 |
Generics |
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs |
Draft |
10/21/2022 |
Biostatistics |
Multiple Endpoints in Clinical Trials |
Final |
10/20/2022 |
Clinical - Medical |
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA |
Final |
10/13/2022 |
Generics |
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA |
Final |
10/5/2022 |
Generics |
Competitive Generic Therapies |
Final |
10/5/2022 |
Generics |
Facility Readiness: Goal Date Decisions Under GDUFA |
Draft |
10/3/2022 |
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) |
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA |
Draft |
10/3/2022 |
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) |
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules |
Final |
10/3/2022 |
Electronic Submissions |
Providing Over-the-Counter Monograph Submissions in Electronic Format |
Draft |
9/27/2022 |
Administrative/Procedural |
Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry |
Final |
9/22/2022 |
Administrative/Procedural |
How To Obtain a Covered Product Authorization |
Draft |
9/21/2022 |
Labeling |
Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products |
Draft |
9/8/2022 |
Labeling |
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products |
Draft |
9/8/2022 |
Real World Data/Real World Evidence (RWD/RWE)
Administrative/Procedural |
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products |
Final |
9/8/2022 |
|
E11A Pediatric Extrapolation |
Draft |
8/26/2022 |
ICH-Multidisciplinary |
M12 Drug Interaction Studies |
Draft |
8/26/2022 |
ICH-Quality |
Q14 Analytical Procedure Development |
Draft |
8/26/2022 |
ICH-Quality |
Q2(R2) Validation of Analytical ProceduresQ14 Analytical Procedure Development |
Draft |
8/26/2022 |
ICH-Efficacy, ICH-Safety |
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers |
Final |
8/26/2022 |
|
|
Generics |
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs |
Draft |
10/21/2022 |
Generics |
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs |
Draft |
10/21/2022 |
Generics |
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs |
Draft |
10/21/2022 |
Biostatistics |
Multiple Endpoints in Clinical Trials |
Final |
10/20/2022 |
Clinical - Medical |
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA |
Final |
10/13/2022 |
Generics |
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA |
Final |
10/5/2022 |
Generics |
Competitive Generic Therapies |
Final |
10/5/2022 |
Generics |
Facility Readiness: Goal Date Decisions Under GDUFA |
Draft |
10/3/2022 |
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) |
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA |
Draft |
10/3/2022 |
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) |
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules |
Final |
10/3/2022 |
Electronic Submissions |
Providing Over-the-Counter Monograph Submissions in Electronic Format |
Draft |
9/27/2022 |
Administrative/Procedural |
Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry |
Final |
9/22/2022 |
Administrative/Procedural |
How To Obtain a Covered Product Authorization |
Draft |
9/21/2022 |
Labeling |
Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products |
Draft |
9/8/2022 |
Labeling |
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products |
Draft |
9/8/2022 |
Real World Data/Real World Evidence (RWD/RWE)
Administrative/Procedural |
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products |
Final |
9/8/2022 |
|
E11A Pediatric Extrapolation |
Draft |
8/26/2022 |
ICH-Multidisciplinary |
M12 Drug Interaction Studies |
Draft |
8/26/2022 |