Drugs
FDA says its review of a Web site operated by Elite Supplement Center and Elite Training Facility, Wayne, NJ, determined that the company is taking orders for five products marketed as selective androgen receptor modulators (SARMs). A 7/6 Warning Letter says the SARMs products are unapproved new drugs that
Biologics
FDA has accepted for review a Byondis BLA for SYD985 ([Vic-] trastuzumab duocarmazine) for use in patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC). The agency has set a user fee review action target date of 5/12/2023. The submission is based on data from
Devices
FDA has granted an emergency use authorization to Watmind USA for its over-the-counter at-home Covid-19 antigen test. The self-test displays results in 15 minutes, and can be used as a “serial test for people with or without symptoms, meaning the test is done two times
FDA Policy/General
Federal Register notice: FDA is revoking an Emergency Use Authorization issued to Fresenius Kabi USA for its Fresenius Propoven 2% Emulsion and its use during the Covid-19 emergency. The company requested the revocation because the product is no longer being made available in the U.S. To view the
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 31 ANDAs from multiple applicants. The applicants notified the agency that the drug products were no longer marketed and requested they be withdrawn. To view the notice, click here.
Biologics
An investigative article in New York Magazine says the lack of monkeypox vaccines in New York City, where cases have risen 370% in the last two weeks, is due in part to a slow FDA response to the need to inspect a vaccine manufacturing facility in Denmark. “As monkeypox cases
Devices
FDA has granted breakthrough device designation to an Abbott deep brain stimulation system for use in treatment-resistant depression, which is classified as a form of major depressive disorder. The company says its system is a personalized, adjustable therapy that involves implanting leads into targeted areas of the brain. A
Devices
FDA says the 5/2 recall by Getinge USA of its Flow-c and Flow-e anesthesia systems due to cracked or broken suction system power switches is Class 1. The company recalled 64 units in the U.S. An FDA notice says the systems are intended to provide inhalation
Drugs
Mylan has recalled one batch of insulin glargine (insulin glargine-yfgn) injection in 3mL prefilled pens that are packaged in cartons of five pens. A company statement posted by FDA says the recalled product is not the branded Semglee pen but the unbranded insulin glargine-yfgn pens. The batch being
Drugs
FDA has published two draft guidances covering portions of the Drug Supply Chain Security Act (DSCSA). The first guidance, DSCSA Standard for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs, identifies the standards necessary to facilitate the adoption of secure, interoperable, electronic data exchange among
Drugs
FDA has sent Warning Letters to five distributors of kratom products, saying that claims made for the products on Web sites and social media establish them as unapproved new drugs that are being illegally delivered into interstate commerce. The 6/30 letters went to Kratom Exchange, Herbsens Botanicals, Klarity Kratom,
Drugs
FDA has told Vertex Pharmaceuticals it can proceed with studies for its diabetes stem cell therapy that was placed on a clinical hold in May. The company says the agency had expressed concerns about a lack of information ahead of the dose-escalation portion of the study. Known as VX-
Drugs
FDA has declined to issue an emergency use authorization (EUA) for NRx Pharmaceuticals’ Zyesami (aviptadil) for a sub-group of patients that received remdesivir in addition to Zyesami and continued to progress. The company said the denial was not unexpected given that the agency had recently denied a breakthrough therapy
Drugs
The FDA Peripheral and Central Nervous System Drugs Advisory Committee will meet on 9/7 to again discuss an Amylyx application for its AMX0035 (sodium phenylbutyrate and taurursodiol) ALS drug that was rejected 6-4 by the committee earlier this year. At that time the committee said Amylyx did not
Devices
FDA has posted a list of enhancements to the CDRH Electronic Medical Device Reporting (eMDR) system. An agency notice says FDA “recognizes the importance of providing early notice and predictability about potential eMDR system changes….” It says it is adopting a yearly schedule for announcing and implementing enhancements to the
FDA Policy/General
Federal Register notice: FDA is correcting the docket number associated with a 6/30 notice on a draft guidance entitled “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” To view the notice, click here.
Drugs
Wellcome Genome researchers in the UK say that for 33 of the 50 (66%) FDA-approved new drugs in 2021, the genes coding for their primary assigned targets, or for proteins that are known to physically interact with the targets, have been previously associated in some way with the indication
FDA Policy/General
FDA Webview has posted the Federal Register notices that published during the week of our annual Fourth of July (Independence Day) holiday break. 7/8/2022 Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Astellas Pharma and Seagen’s Padcev (enfortumab vedotin-ejfv)
Drugs
U.S. Rep. Abigail Spanberger (D-VA) has introduced a bill entitled the Banning Misleading Drugs Act that is intended to prevent manufacturers from obscuring dangerous side effects of their prescription drugs in their advertisements and to help consumers make informed decisions. The measure would require FDA to finalize a
Drugs
HRA Pharma, a Perrigo company, has submitted an NDA that, if approved, would be the first over-the-counter (OTC) birth control pill in the U.S. The Rx-to-OTC switch application is for the company’s Opill (norgestrel .075 mg), a progestin-only daily birth control pill (also
Drugs
Former CDER Office of Generic Drugs Division of Legal and Regulatory Support deputy director Martin H. Shimer II has joined Lachman Consultants after a 22-year career at the agency. At the ANDA consulting firm, Shimer will “assist clients with regulatory submissions and strategy, communications with FDA, and navigating the
Drugs
The National Hemophilia Foundation says FDA should require Risk Evaluation and Mitigation Strategies (REMS) if it approves two investigational gene therapies to treat hemophilia. The foundation’s 7/1 petition says REMS should be required for BioMarin’s valotocogene roxaparvovec, under regulatory review to treat severe hemophilia A, and CSL