FDA Policy/General
A 7/22-8/9/19 FDA inspection at Rapid Equine Solutions, Aston, PA, found that animal drug products compounded by the firm are adulterated and misbranded. A 6/12 Warning Letter says the agency inspection followed the death of three horses that were given an animal drug compounded by
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 12 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Two George Mason University Mercatus Center researchers say FDA’s food regulation responsibilities should be given to the Agriculture Department or some other entity to focus FDA efforts just on regulating medical products. In an online opinion column for The Hill, the researchers suggest that FDA has failed dramatically in
FDA Policy/General
Federal Register notice: FDA has determined that Promius Pharma’s Tenex (guanfacine HCl) tablets, 1mg, 2mg,and 3mg were not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal
FDA Policy/General
FDA commissioner Stephen Hahn says the agency “has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years.” Writing in an online post to praise agency staff for their efforts, Hahn says FDA is on
FDA Policy/General
Federal Register notice: FDA has determined that dextrose in plastic container injectable, 30g/100mL, 40g/100mL, 60g/100mL, and 70g/100mL, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs for such generic products. To view the notice, click
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. BHP Holdings, Woodinville, WA (6/17): FDA inspected the company 10/2019 and cited GMP violations for dietary supplements. For example, BHP failed to review all product complaints to
FDA Policy/General
FDA’s Center for Veterinary Medicine has launched its Export Certification Application and Tracking System (CVM eCATS), a new online system that allows U.S. animal food, drug and device manufacturers to apply for, track and receive export certificates electronically for CVM-regulated animal products. Previously, CVM-regulated product makers
FDA Policy/General
DEVICES FDA has approved an Endomagnetics Inc. PMA for the Magtrace and Sentimag Magnetic Localization System, a device for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The device uses magnetic detection during sentinel lymph node biopsy procedures to identify specific (sentinel) lymph nodes for surgical removal,
FDA Policy/General
Federal Register notice: FDA has announced a 7/14 online/teleconferencing Oncologic Drugs Advisory Committee meeting. The panel is scheduled to discuss a GlaxoSmithKline BLA for belantamab mafodotin, indicated for treating adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38
FDA Policy/General
Federal Register notice: FDA is correcting a 2/12/2019 notice that announced the withdrawal of approval of 12 ANDAs from multiple applicants. That notice erroneously included ANDA 077736 for polyethylene glycol 3350 powder for oral solution held by Breckenridge Pharmaceutical. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.” The document is the first in a series of four methodological guidance documents that FDA committed to develop to address in a stepwise manner how to collect and submit information
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities” (OMB Control Number0910-0883). FDA intends to conduct research to understand better the challenges and opportunities encountered by the outsourcing facility sector in a number
FDA Policy/General
Federal Register notice: FDA is requesting nominations for members to serve on its Pharmacy Compounding Advisory Committee. The panel provides advice on scientific, technical, and medical issues concerning human drug compounding. To view the notice, click here.
FDA Policy/General
University of California San Francisco resident surgeon Nisarg Patel says FDA should be restructured as an independent agency to help protect it from the political pressures that have affected it for several decades and have been particularly obvious during the Covid-19 pandemic. Writing in a Politico opinion column, Patel
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Data To Support Drug Product Communications as Used by the Food and Drug Administration” (OMB Control Number 0910-0695). The collection supports agency outreach efforts. FDA says testing of communication messages in advance of a communication campaign
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision for “Protection of Human Subjects and Institutional Review Boards; Certificates of Confidentiality” (OMB Control Number 0910-0130). The Cures Act broadened the protections by prohibiting certificate holders from disclosing such information unless a specific exception applies. The revision
FDA Policy/General
Federal Register notice: FDA is correcting a 3/9 notice that announced the withdrawal of approval of 16 ANDAs abbreviated from multiple applicants. The correction notes that Lupin Pharmaceuticals informed FDA that it did not want the approval of four ANDAs withdrawn. Accordingly, the approval of ANDAs 065488, 078410, 090441,
Drugs
The DC Circuit Court of Appeals has upheld a federal district court decision rejecting an HHS rule that broadly required drug manufacturers to disclose in their TV ads the wholesale acquisition cost of many prescription drugs and biologics for which payment is available under Medicare or Medicaid. The appeals court
FDA Policy/General
The Alliance for a Stronger FDA reports in its Friday Update that the House and Senate appropriations committees will hold mark-up sessions in late June and July for the FY 21 appropriations bill. They have not yet indicated specific dates for consideration of specific bills. The online newsletter’s
FDA Policy/General
Federal Register notice: FDA has extended until 10/15 the comment period on (XXX INSERT, DELETE XXX) a draft guidance for industry #256 entitled “Compounding Animal Drugs from Bulk Drug Substances.” FDA is taking this action in response to requests for an extension to allow interested persons additional time to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form FDA 3601a” (OMB Control Number 0910-0511).The revision adds form FDA 3601a, the Device Facility User Fee Cover Sheet.