FDA Policy/General
Federal Register notice: FDA is issuing an order permanently debarring Jonathan R. Shaver from providing services in any capacity to a person that has an approved or pending drug product application. The FDA action is based on Shaver’s felony conviction for conspiring to distribute misbranded and counterfeit cough syrup
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Richard B. Smith III for five years from importing or offering for import any drug into the U.S. The agency bases the action on Smith’s felony conviction for receiving misbranded drugs in interstate commerce and delivering them for pay
FDA Policy/General
Federal Register notice: FDA is reopening the comment period on an 11/20/2023 request for information that is intended to better understand the status of trading partners’ interoperable systems and processes for enhanced drug distribution security as required by the Food, Drug and Cosmetic Act (FD&C Act)
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.” The collection supports the agency’s compounding program that is intended to protect patients from unsafe, ineffective,
FDA Policy/General
A House Appropriations subcommittee 6/11 voted out a fiscal year 2025 budget for FDA that slashes President Biden’s recently requested agency funding by $450 million (6%). In March, Biden proposed $7.2 billion for FDA (see story), but now the subcommittee markup has only approved $6.75 billion,
FDA Policy/General
Federal Register notice: CDER is announcing the Emerging Drug Safety Technology Meeting program, intended to provide stakeholders involved in pharmacovigilance (PV) activities an opportunity to meet with CDER staff to discuss their research, development, and use of artificial intelligence and other emerging technologies in PV. The Center says the program’
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Arthritis Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/5/2026. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/23/2026. To view the notice, click here.
FDA Policy/General
Federal Register notice: CDER is publishing a proposal to refuse the approval of a supplemental NDA submitted by Vanda Pharmaceuticals for Hetlioz (tasimelteon) capsules, 20 mg, indicated for treating insomnia characterized by difficulties with sleep initiation. The notice summarizes the grounds for not approving the supplement and offers Vanda an
FDA Policy/General
Federal Register notice: FDA is announcing a 7/25 Oncologic Drugs Advisory Committee meeting to discuss an AstraZeneca supplemental BLA for Imfinzi (durvalumab) injection. The company is seeking an indication for combination use with chemotherapy as neoadjuvant treatment, followed by Imfinzi as monotherapy after surgery, for treating adult patients with
FDA Policy/General
FDA has cleared a DePuy Synthes 510(k) for the VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty (UKA). The expanded indication builds upon the device’s cleared use in total knee arthroplasty. Depuy says UKA (partial knee replacement) offers the potential for bone preservation and shortened
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Marina Sievert for 10 years from importing or offering for import any drug into the U.S. The order is based on her felony conviction for operating the Web site www.beautyforeverflorida.com where she sold a variety of foreign unapproved
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Prescription Drug Marketing.” The collection supports the agency’s regulations and statutory requirements that govern prescription drug marketing and requirements for the: (1) reimportation and wholesale distribution of prescription drugs; (2) sale, purchase, or trade of, or
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The document was mandated by the Food and Drug Omnibus Reform Act of 2022, which directs the agency to issue guidance describing the processes and practices applicable to such
FDA Policy/General
Federal Register notice: FDA is withdrawing 23 NDAs from multiple applicants after being notified by the application holders that the products were no longer marketed and requesting that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Device Recall Authority — 21 CFR Part 810.” The collection supports agency regulations that set forth mandatory medical device recall authority provisions. For example, it covers FDA’s authority to issue a recall order if it finds
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Michael Terry Little for five years from importing or offering for import any drug into the U.S. The debarment is based on Little’s felony conviction for introducing unapproved new drugs in interstate commerce from 3/2018 to 1/2022
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Shanif Abdul Punjani for five years from importing or offering for import any drug into the U.S. The debarment is based on Punjani’s felony conviction for conspiracy to defraud the U.S. by importing thousands of Aurogra 100mg sildenafil
FDA Policy/General
Federal Register final rule: FDA is issuing a regulation to implement its authority to destroy a device valued at $2,500 or less that has been refused admission into the U.S. by providing to the owner or consignee a notice and an opportunity to appear and introduce testimony prior
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance “Platform Technology Designation Program for Drug Development.” The document provides details about implementing the agency’s Platform Technology Designation Program, which was established by the PREVENT Pandemics Act. It outlines eligibility factors for receiving a platform technology designation, potential benefits
FDA Policy/General
Federal Register notice: FDA is announcing its decision to terminate the Science Advisory Board to the National Center for Toxicological Research (NCTR), otherwise known as “the committee.” The agency says the advisory board was established in 1973, but it has met very infrequently over the past few years, adding that
FDA Policy/General
FDA says its proposed reorganization involving changes in the functioning of the Office of Regulatory Affairs, with a new model for field operations, the creation of a unified Human Foods Program, and other efforts has been approved. An agency notice says implementation of the reorganization is targeted for 10/1.