Titles
- 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
- Orphan drugs: FDA could improve designation review consistency; rare disease drug development challenges continue : report to Congressional requesters1
- Providing regulatory submissions in electronic format: certain human pharmaceutical product applications and related submissions using the eCTD specifications1
- Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 1(R1) : residue on ignition/sulphated ash general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 10(R1) : polyacrylamide gel electrophoresis general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 2(R1) : test for extractable volume of parenteral preparations general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 3(R1) : test for particulate contamination : subvisible particles general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4A(R1) : microbiological examination of nonsterile products : microbial enumeration tests general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4B(R1) : microbiological examination of nonsterile products : tests for specified microorganisms general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4C(R1) : microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 5(R1) : disintegration test general chapter1