- Investigational new drugs: FDA's expanded access program : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives1
- Low-dose radiation: interagency collaboration on planning research could improve information on health effects : testimony before the Subcommittee on Energy, Committee on Science, Space, and Technology, House of Representatives1
- M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use1
- M4E(R2): the CTD--efficacy1
- Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff1
- Memory supplements: clarifying FDA and FTC roles could strengthen oversight and enhance consumer awareness : report to Congressional requesters1
- Nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV): testing, product disposition, and donor deferral and reentry1
- Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff1
- Procedures for meetings of the Medical Devices Advisory Committee: guidance for industry and Food and Drug Administration staff1
- Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff1
- Product name placement, size, and prominence in promotional labeling and advertisements1
- Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications1
- Q3C--tables and list1
- 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 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