- Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff1
- Formal meetings between FDA and ANDA applicants of complex products under GDUFA1
- Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry1
- Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance1
- Generic drugs: FDA should make public its plans to issue and revise guidance on nonbiological complex drugs : report to Congressional requesters1
- Health document submission requirements for tobacco products: (revised)1
- Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment1
- Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination1
- Investigational new drugs: FDA has taken steps to improve the expanded access program but should further clarify how adverse events data are used : report to Congressional addressees1
- M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use1
- M4E(R2): the CTD--efficacy1
- Maximal usage trials for topically applied active ingredients being considered for inclusion in an over-the -counter monograph: study elements and considerations1
- Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application1
- One percent of drugs with Medicaid reimbursement were not FDA-approved1
- Orange Book: questions and answers1
- Orphan drugs: FDA could improve designation review consistency; rare disease drug development challenges continue : report to Congressional requesters1
- Population pharmacokinetics1
- Pre-Launch Activities Importation Requests (PLAIR)1
- Principles of premarket pathways for combination products: guidance for industry and FDA Staff1
- Protecting participants in bioequivalence studies for abbreviated new drug applications during the COVID-19 public health emergency1