FDA Policy/General
Quest Diagnostics has completed its acquisition of Cleveland HeartLab, which allows Quest to establish a national center of excellence focused on heart disease diagnostics within Cleveland HeartLab's existing 25,000 square-foot clinical laboratory facility in Cleveland. In connection with the acquisition, Quest and Cleveland Clinic have finalized
FDA Policy/General
Federal Register notice: FDA is announcing the rates for prescription drug user fees for fiscal year 2022. The fee for an application requiring clinical data is $3,117,218; for an application not requiring clinical data $1,558,609, and for the prescription drug program $369,413. The fees are
FDA Policy/General
Federal Register notice: FDA has established a public docket to solicit comments on several issues related to FDA’s post-approval regulation of certain drug products approved in abbreviated applications before the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments) amended the Federal Food, Drug,
FDA Policy/General
Federal Register notice: FDA has announced a 10/6 Patient Engagement Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on medical device recalls. Specifically, it will address when a company may recall a device after discovering a problem on its own, or after FDA raises concerns.
FDA Policy/General
CNN reports that the Biden administration has considered several people in its search for a permanent FDA commissioner who can win Senate approval and has come up short. “Two officials said it could be ‘weeks’ before Biden settles on anyone,” the online story says. The network reports the White House
FDA Policy/General
Federal Register notice: FDA is seeking consumer organizations interested in participating in the selection of voting and nonvoting consumer representatives to serve on its advisory committees. The agency is also requesting nominations for voting and nonvoting consumer representatives to serve on advisory committees. Nominees may be self-nominated or may
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. They are: * Infant Formula Requirements (OMB control # 0910–0256) * Shortages Data Collection (OMB control # 0910–0491) * Guidance on Labeling for Natural
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. BBC Group, Pumei Town, China (8/4): FDA inspected the firm 3/22-26 and cited significant GMP violations for finished drugs. The agency said BBC failed to exercise
FDA Policy/General
Federal Register notice: FDA has announced a 9/17 Pediatric Advisory Committee to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. Panel members are scheduled to review Cook Medical’s Flourish, a pediatric esophageal atresia device
FDA Policy/General
Federal Register notice: FDA has established a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between 9/2/2020 and 9/2/2021 on FDA’s Web site, but not presented at the upcoming 9/17 Pediatric Advisory Committee meeting. Comments
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials. The document provides the agency’s expectations for collection, analysis, and reporting of data pertaining to metastasis-free survival. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Development and Submission of Near Infrared Analytical Procedures.” The document provides recommendations to applicants to aid the development, validation, and use of near infrared-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances
FDA Policy/General
The White House is denying that a rumored candidate for FDA commissioner, former Obama White House advisor Ezekiel J. Emanuel, is in the running for the agency top job. First reported by Politico, hours later it was denied by White House spokesman Kevin Munoz. “Dr. Emanuel is not in the
FDA Policy/General
Federal Register notice: FDA has announced its implementation of a decision from the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA. The 4/16 decision affirmed a district court ruling that FDA is not afforded discretion when a combination product
FDA Policy/General
Federal Register notice: FDA is extending the period for states to decide whether to sign the final standard memorandum of understanding (MOU) entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the [insert State Board of Pharmacy or Other Appropriate State Agency] and the U.S.
FDA Policy/General
Federal Register notice: FDA has announced a public workshop entitled “Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design.” The agency says that complex and innovative trial designs have the potential to optimize drug development in small populations. Innovations that have been proposed include Bayesian and other methods of
FDA Policy/General
A Spherix Global Insights survey of 252 specialists in dermatology, gastroenterology, nephrology, neurology, and rheumatology found that confidence in FDA is swiftly diminishing. The survey says only 36% of respondents expressed a high level of assurance in the agency, with nearly one-half saying their confidence in FDA has eroded
FDA Policy/General
Federal Register notice: FDA is updating its listing of Emergency Use Authorizations (EUAs) for use during the Covid-19 pandemic. It has been updated to reflect a 5/26 EUA for GlaxoSmithKline’s sotrovimab, and a 6/24 EUA for Genentech’s Actemra (tocilizumab). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that Novartis’ Votrient (pazopanib hydrochloride) tablets, 400 mg, were not withdrawn from sale due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Votrient is a kinase
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 6/24 notice on a draft guidance entitled Remanufacturing of Medical Devices. Comments can now be submitted until 9/22. The guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.” The document says such
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Device Recall Authority--21 CFR Part 810” (Control Number 0910-0432). Section 518(e) of the Federal Food, Drug, and Cosmetic Act provides FDA with the authority in certain instances to issue an order requiring companies
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 6/4 notice about a draft guidance entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act. (XXX ITALICIZE ENTIRE TITLE XXX) Comments are now being accepted until 9/2. To view the