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This week, the FDA published a final guidance on clinical considerations for studies of opioid use devices. Draft guidances were issued for misinformation about drugs and devices, use-related risk analyses and 510(k) submissions for dental composite resins and dental curing lights. Read More
This week, the FDA published a draft guidance on drug delivery outputs for devices used to deliver drugs and general principles on plan, design, and analysis of pharmacoepidemiological studies. Read More
This week, the FDA published a final guidance for small businesses on LDTs. The long-awaited draft guidance on diversity in clinical trials was also published. The agency modified its list of recognized standards and is seeking comments on its IT and customer experience strategies. Read More
This week, the FDA published a final rule on medical gases. Final guidance was issued on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. Final guidance was also issued on drug development for diabetic foot infections, bioanalytical method validation and study samples, clinical pharmacology, and date decisions under GDUFA. Draft guidance was published on demonstrating interchangeability. The agency is also seeking nonvoting industry members for its advisory committees. Read More
This week, the FDA requested information and comments on enhanced drug distribution security requirements. The agency is also seeking nominations for its advisory committees and has amended the OTC monograph for analgesic, antipyretic and antirheumatic drugs. Read More
This week, the FDA issued a final rules related to the administrative destruction of medical devices that are thought to be counterfeit and announcing the termination of the Science Advisory Board to the National Center for Toxicological Research. Draft guidance was published on the platform technology designation program for drug development. Read More
This week, the FDA issued a final rule reclassifying ultrasound cyclodestructive devices and published a notice seeking nominations for advisory panels of the Medical Devices Advisory Committee. Read More
This week, the FDA announced its final rule for laboratory developed tests. Draft guidances were published on enforcement policies for tests during a Section 564 declared emergency, IVD enforcement policy in the absence of a Section 564 emergency declaration and a REMS logic model. Advisory committee meetings were announced for Donanemab, Lilly’s Alzheimer’s drug and for Midomafetamine capsules. Read More
This week, the FDA announced a Metabolic Drugs Advisory Committee meeting and a listening session on advisory committees. Draft guidances were published on content and format of NDA and ANDA labeling statements, use of human- and animal-derived materials in the manufacture of CGT and TEMP products, safety testing of human allogeneic cells. Read More
This week, the FDA announced a Medical Devices Advisory Committee meeting, availability of a report on postmarketing performance of drug firms, revised draft guidance on biologic promotional labeling and advertising, three draft guidances on cancer clinical trial eligibility criteria, and a request for comments on promoting effective drug development. Read More