Devices
An FDA discussion paper on laboratory developed tests (LDTs) outlines a new proposal to provide oversight of such devices. Recently, the agency announced that it would not issue a final guidance on LDT oversight at the request of various stakeholders to allow for further public discussion on an appropriate oversight
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Emergency Use Authorization of Medical Products and Related Authorities.” The document outlines FDA’s current thinking on the authorization of the emergency use of certain medical products under sections of the Federal Food, Drug, and Cosmetic Act as amended by
Drugs
FDA has posted a draft guidance on “Referencing Approved Drug Products in ANDA Submissions” that provides information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in ANDA submissions. A reference standard selected by FDA is the specific drug product
FDA Policy/General
President-elect Donald Trump’s pick to serve as HHS secretary, House Budget Committee chair Tom Price (R-GA) (see earlier story), has agreed to divest stock ownership in over 40 companies if his appointment is confirmed by the Senate. One potential divesture involves a tiny Australian biotech, Innate Immunotherapeutics,
Drugs
The International Council for Harmonization (ICH) is looking to “renovate” its guidelines on good clinical practice. A new white paper from the group entitled “ICH Reflection on ‘GCP Renovation’: Modernization of ICH E8 and Subsequent Renovation of ICH E6” outlines an approach to update guidelines on clinical trial design, planning,
FDA Policy/General
FDA Webview’s newsroom will be closed Monday (1/16) in observance of Martin Luther King day. Nightly emails will resume 1/17.
Drugs
FDA has issued two guidances on human drug compounding. The first, Repackaging of Certain Human Drug Products by State-Licensed Pharmacies and Outsourcing Facilities, has been issued in final form to describe the conditions under which FDA does not intend to take action for certain violations of the Federal Food,
Drugs
FDA says that consumers should not purchase or use PNC-27, a product promoted online as a treatment or cure for cancer. An agency drug safety communication says that an agency laboratory discovered the bacteria Variovorax paradoxus in a PNC-27 solution sample for inhalation. The notice says FDA has
Drugs
FDA has issued a guidance, Nonproprietary Naming of Biological Products, calling for biological products licensed under the Public Health Service Act to have a nonproprietary name that includes an FDA-designated four-letter suffix. The document says that under this convention, the “nonproprietary name for each originator biological product, related
FDA Policy/General
Senate HELP Committee chairman Lamar Alexander (R-TN) says Senate confirmation of HHS secretary-designate Tom Price may not come until mid-February, meaning that introduction of a replacement for the Affordable Care Act likely would not come until the beginning of March. Roll Call reports that Alexander made the
Drugs
FDA has posted a draft guidance on “180-Day Exclusivity: Questions and Answers” that addresses questions that have been raised about Food, Drug, and Cosmetic Act provisions related to generic drug exclusivity. The agency believes such a guidance “would enhance transparency and facilitate the development, approval, and timely marketing of
Drugs
FDA has released a draft guidance on “Multiple Endpoints in Clinical Trials” that discusses the problems posed by multiple endpoints in the analysis and interpretation of drug/biologic study results and how these problems can be managed in clinical trials. Most drug clinical trials contain multiple endpoints to assess the
Drugs
Kremers Urban Pharmaceuticals says FDA has ignored two Freedom of Information Act (FOIA) requests for information on its ANDA for extended-release methylphenidate tablets for which the agency says it intends to withdraw approval. The company filed suit in DC district court, saying it received an agency 10/17/16
Devices
FDA has released a final guidance on “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions.” The document is intended to provide greater clarity on the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical studies. The
FDA Policy/General
President-elect Donald Trump 1/12 reportedly met with two Silicon Valley associates of billionaire tech investor Peter Thiel (see earlier story) for potential posts at FDA, according to The Hill. Trump interviewed Jim O’Neil, a managing director of one of Theil’s venture capital firms, who is high
FDA Policy/General
Federal Register Final Order: FDA has reclassified antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from Class 1 into Class 2 with special controls and into a new device classification regulation.
FDA Policy/General
Federal Register Notice: FDA has announced a 3/9 Vaccines and Related Biological Products Advisory Committee meeting. Panel members will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017–2018 influenza season. To view
FDA Policy/General
Federal Register Notice: FDA has announced a 3/17 joint Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee meeting. Panel members will discuss and make recommendations on potential risks related to misuse of peroxide-based contact lens products. Specific issues to be discussed
FDA Policy/General
Federal Register Notice: FDA has announced a 3/13 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. Panel members will be asked to discuss safety issues related to Endo Pharmaceuticals’ Opana ER (oxymorphone hydrochloride) extended-release tablets, indicated
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.” The document is intended to inform manufacturers, members of the medical and scientific community, and other interested persons that at this time FDA
Drugs
FDA has granted RedHill Biopharma a Qualified Infectious Disease Product (QIDP) designation for RHB-104 and its use in treating Nontuberculous Mycobacteria (NTM) infections. The QIDP designation was granted under the Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for treating serious
FDA Policy/General
FDA and IBM Watson Health have agreed on a two-year research initiative to define a secure, efficient, and scalable exchange of healthcare data using blockchain technology. An IBM statement says that the two parties will explore the exchange of owner-mediated data from several sources such as electronic medical