FDA Policy/General
Federal Register notice: FDA has determined that Valeant Pharmaceuticals’ Pepcid (famotidine) tablets, 20 mg and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. Pepcid is indicated in adult and pediatric patients for treating active duodenal ulcer, active gastric ulcer, symptomatic nonerosive gastroesophageal reflux disease, and
FDA Policy/General
Federal Register notice: FDA is classifying electrocardiograph software for over-the-counter use into medical device Class 2 (special controls). The action is based on an Apple Inc. request for de novo classification of its ECG App. The device is identified as one that creates, analyzes, and displays electrocardiograph data
FDA Policy/General
Federal Register notice: FDA is announcing a 3/10 virtual public hearing on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox, a carcinogenic new animal drug used in swine feed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is revoking the Emergency Use Authorizations (EUAs) issued to Becton, Dickinson (BD) for the BioGX SARS–CoV–2 Reagents for BD MAX System, Boston Medical Center (BMC) for the BMC–CReM COVID–19 Test, and Akron Children’s Hospital (ACH) for the Akron Children’s Hospital
FDA Policy/General
The Senate Health, Education, Labor & Pensions Committee 1/13 voted 13 to 8 to move FDA commissioner nominee Robert Califf’s nomination to an eventual Senate floor vote. On the Democrat side, two votes were against the nomination — Bernie Sanders (I-VT) and Maggie Hassan (D-NH). This was
FDA Policy/General
Federal Register notice: FDA is issuing a final rule to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to 5/25/2005. The revocation does not affect regulations for human cells, tissues, and cellular and tissue-based products recovered on or after May
FDA Policy/General
Federal Register notice: FDA has issued a final rule to amend the medical device regulations on procedures for announcing approvals and denials of PMAs and HDEs. The final rule discontinues the publication in the Federal Register each quarter of a list of recent PMA and HDE approvals and denials. Instead,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act. The agency requires device manufacturers to notify it about a permanent discontinuance or an interruption in a
FDA Policy/General
As the omicron variant spreads out of control and related hospitalizations are breaking previous Covid-19 records, FDA acting commissioner Janet Woodcock told a Senate Health, Education, Labor & Pensions hearing 1/11 that this is not the time to think about different approaches to combat Covid-19 or determine
FDA Policy/General
Federal Register notice: FDA is correcting a notice in the 11/1/2021 Federal Register that announced the regulatory review period for Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki), indicated for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Drug Supply Chain Security Act Implementation” (OMB Control Number 0910-0806). The collection supports the agency’s implementation of provisions in Section 582 of the Federal Food, Drug, and Cosmetic Act regarding the pharmaceutical distribution supply chain.
FDA Policy/General
Public Meeting on Generic Drug User Fees 1/7/2022 Federal Register notice: FDA has announced an 2/16 public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2023 through 2027. To view the notice, click here. 4 Information Collections
FDA Policy/General
DEVICES FDA has approved a Sientra PMA supplement allowing commercialization of its Opus-branded breast implant products manufactured by Vesta, a Lubrizol LifeSciences company, at Vesta’s Wisconsin-based manufacturing facility. The devices are being made under “an improved manufacturing process,” according to Sientra. FDA has cleared a Varian 510(
FDA Policy/General
GliaCure has begun dosing Alzheimer’s patients in a Phase 1b clinical trial of its GC021109 to evaluate safety and tolerability. The company says its approach promotes the clearance of amyloid and stimulates anti-inflammatory actions through a single target. Bayer HealthCare has entered into an exclusive license agreement with
FDA Policy/General
Federal Register notice: FDA has announced that CDER, CBER, CDRH and Center for Tobacco Products have modified their organizational structures, which were approved by HHS 11/24/2021. To view the notice, click here.
FDA Policy/General
A revised Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals took effect 1/1. Attorney Faraz Siddiqui (Hyman, Phelps & McNamara) says many of the code’s changes involve drug manufacturer practices covering speaker events, including meals, choice of venue, and attendance. Writing in his
FDA Policy/General
Faced with safety concerns from the quick spreading omicron coronavirus variant, FDA says it has temporarily postponed all face-to-face domestic and foreign inspectional work except for “mission-critical” inspections. The inspection pause is expected to last until 1/19. FDA notes that while it will continue conducting mission-
FDA Policy/General
Federal Register notice: FDA has announced that its Office of the Chief Scientist has modified its organizational structure, which was approved by HHS 11/24/2021. To view the notice, click here.
FDA Policy/General
A Stat opinion column written by Columbia University Vagelos College of Physicians and Surgeons psychiatry department chair Jeffrey Lieberman criticizes Democrats who have expressed concerns about the nomination of Robert Califf as FDA commissioner. The column specifically cites Sens. Bernie Sanders (I-VT), Elizabeth Warren (D-MA), and Joe Manchin
FDA Policy/General
Federal Register notice: FDA has issued an order debarring William Kulakevich for five years from importing or offering for import any drug into the U.S. The debarment is based on Kulakevich’s previous felony conviction related to asetizolam sales to consumers through his Web site (www.etizy.com). The
FDA Policy/General
The Senate Health, Education, Labor & Pensions Committee has pushed back a 1/5-scheduled confirmation vote on FDA commissioner nominee Robert Califf until 1/15. No explanation for the delay has been given, but some are speculating on weather effects after the Washington, DC region was slammed by a
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities” (OMB Control Number 0910-0883). To view the notice, click here.