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Titles
- M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use1
- M4E(R2): the CTD--efficacy1
- M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk1
- Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff1
- Marketing clearance of diagnostic ultrasound systems and transducers: guidance for industry and Food and Drug Administration staff1
- Marketing status notifications under Section 506I of the Federal Food, Drug, and Cosmetic Act: content and format1
- Maximal usage trials for topically applied active ingredients being considered for inclusion in an over-the -counter monograph: study elements and considerations1
- Measuring up?: end-of-life cancer care in California1
- Medical devices1
- Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices): guidance for industry and Food and Drug Administration staff1
- Medical product communications that are consistent with the FDA-required labeling: questions and answers1
- Medical x-ray imaging devices conformance: 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
- Metal expandable biliary stents: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration Staff1
- Microdose radiopharmaceutical diagnostic drugs: nonclinical study recommendations1
- Migraine: developing drugs for acute treatment1
- Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application1
- Most hospitals obtain compounded drugs from outsourcing facilities, which must meet FDA quality standards1