Latest Federal Register Notices
Info Collection for Device Corrections/Removals
Federal Register notice: FDA seeks comments on an information collection extension for “Medical Devices; Reports of Corrections and Removals — 21 CFR Part 806” (OMB Control Number 0910-0359). 02/21/2020
Final Rule Defines ‘Biological Product’
Federal Register final rule: FDA issues a final rule to amend its regulation that defines “biological product” to incorporate changes made by legislation, and to provide the interpretation of the statutory term “protein.” 02/21/2020
FDA Reclassifying Certain HIV Tests
Federal Register proposed order. FDA proposed to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid diagnostic and supplemental tests from Class 3 into Class 2. 02/21/2020
Info Collection on Custom Device Exemption
Federal Register notice: FDA seeks comments on an information collection extension for “Annual Reporting for Custom Device Exemption.” 02/21/2020
Device Panel to Review 5 Classifications
Federal Register notice: FDA announces a 4/23-24 Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting. 02/21/2020
15 ‘No Longer Marketed’ ANDAs Withdrawn
Federal Register notice: FDA withdraws approval of 15 ANDAs from multiple applicants after notifying the agency that they are no longer marketed. 02/21/2020
Comments Reopened on Animal Drug Compounding
Federal Register notice: FDA reopens the comment period for an 11/20/2019 notice seeking comments on “Guidance for Industry #256 — Compounding Animal Drugs from Bulk Drug Substances.” 02/20/2020
Nonclinical Evaluation of Immunotoxicity Guide
Federal Register notice: FDA makes available a draft guidance entitled “Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics.” 02/20/2020
Panel to Review Glaxo Trelegy Ellipta sNDA
Federal Register notice: FDA announces a 4/21 Pulmonary-Allergy Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Trelegy Ellipta and its use for reducing all-cause mortality in COPD patients. 02/19/2020
Medical Imaging Panel to Review Alzheimer’s Diagnostic
Federal Register notice: FDA announces a 4/23 Medical Imaging Drugs Advisory Committee meeting to review an Avid Radiopharmaceuticals NDA for a radioactive diagnostic agent for positron emission tomography brain imaging in Alzheimer’s patients. 02/19/2020
Docket Opened for Vaping Injury Reports
Federal Register notice: FDA opens a docket to obtain information about vaping products and associated lung injuries. 02/18/2020
Reg Review Period for Endorecherche’s Intrarosa
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Endorecherche’s Intrarosa (prasterone). 02/18/2020
Stimulant Use Disorder Drug Development Meeting
Federal Register notice: FDA announces a 3/10 public meeting entitled “Patient-Focused Drug Development for Stimulant Use Disorder.” 02/18/2020