Drugs
FDA says it is working with the Department of Defense (DoD) to prioritize efficient development of medical products intended to save the lives of American military personnel. A FDA announcement says the program framework comes through legislation that authorized the Defense Department to request, and FDA to provide, assistance to
Drugs
A 7/31-8/3/17 FDA inspection at Shanwei Honghui Daily Appliance Co., Ltd., Shanwei, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/5/17 Warning Letter. Specific violations cited in the letter were: * failing to clean, maintain, and,
Drugs
An FDA drug safety alert says Tesaro’s Varubi (rolapitant) injectable emulsion has been associated with anaphylaxis and other serious hypersensitivity reactions. The product is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). The reactions have occurred during or soon after the infusion of Varubi, with most
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Becton Dickinson Franklin Lakes, NJ (1/11): FDA inspected the firm 7/2017 and determined that the firm did not gain clearance for device modifications to its BD Vacutainer
Devices
The Department of Justice (DoJ) says a second individual has pleaded guilty in connection with a scheme to defraud consumers by selling laser devices as a treatment for more than 200 different diseases and disorders. A department news statement says Irina Kossovskaia, of Ontario, Canada, pleaded guilty in South Dakota
Drugs
FDA has launched a new pilot to offer more transparency with drug approval decisions. “One place where we are evaluating how we can release information that may better inform scientists, providers, and patients is clinical study reports (CSRs),” FDA commissioner Scott Gottlieb said 1/16. A CSR is the portion
Devices
Sens. Edward Markey and Elizabeth Warren (both D-MA) have reintroduced legislation (S. 2287) to eliminate the 2.3% excise tax on medical devices. The tax first took effect 1/2013 as part of the Affordable Care Act. Congress suspended it for 2016 and 2017, but it was reinstated 1/
Drugs
A 5/22-5/26/17 FDA inspection at Wuhan Chinese Moxibustion Technology Dev. Co., Ltd., Wuhan, Hubei, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/18/17 Warning Letter. Specific violations cited in the letter were: * failing to establish
Drugs
The Government Accountability Office (GAO) says FDA should announce its plans to issue and revise product-specific guidance for drugs that are nonbiological and complex. FDA agreed with the recommendation that was included in a GAO report assessing the FDA process for reviewing generic versions of nonbiological complex drugs (NBCDs)
Devices
FDA will publish in the 1/17 Federal Register a notice proposing to implement regulations on internal agency supervisory review of certain decisions related to medical devices regulated by CDRH to conform to applicable provisions of the FDA Safety and Innovation Act and the 21st Century Cures Act. The notice
Drugs
Public Citizen Health Research Group director Michael Carome says those interested in providing patients additional access to unapproved medications should press Congress for legislation to further enhance FDA’s expanded access program, rather than backing “right-to-try” legislation that would undermine the program. Writing in an online Stat News
FDA Policy/General
Regulatory Review Period Determined for Uromedica’s Proact Federal Register notice: FDA determines that the regulatory review period for Uromedica’s Proact Adjustable Continence Therapy For Men was 3,892 days. 01/12/2018 Comments Extended for Guide on Submitting ANDA/505(b)(2) Federal Register notice: FDA reopens the
FDA Policy/General
FDA Webview’s newsroom will be closed Monday (1/15) in observance of Martin Luther King day. Nightly emails will resume 1/16.
Drugs
FDA has expanded the approved use of AstraZeneca’s Lynparza (olaparib tablets) to include treating patients with certain types of breast cancer that have metastasized and whose tumors have a specific genetic mutation. The agency says it is the first PARP inhibitor approved to treat breast cancer, and it is
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for Uromedica’s Proact Adjustable Continence Therapy For Men was 3,892 days. Of this time, 3,179 days occurred during the testing phase and 713 days occurred during the approval phase. The device is indicated for treating adult
FDA Policy/General
Federal Register notice: FDA has reopened the comment period until 2/12 on a draft guidance on “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” The document is intended to assist applicants in determining which one of the abbreviated approval pathways is appropriate for submitting a
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a draft guidance entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” Submit either electronic or written comments by 2/18. To view the notice, click here.
Drugs
A new CDER regulatory science report details the agency’s efforts to ease bioequivalence (BE) requirements for locally-acting orally inhaled and nasal drug products (OINDPs). The report emphasizes the challenges to demonstrate BE for proposed generic OINDPs since the traditional PK [pharmacokinetic] approach used for systemically acting drugs is
Devices
FDA has released a guidance on “Unique Device Identification (UDI): Policy Regarding Compliance Dates for Class I and Unclassified Devices.” The agency’s UDI system is designed to identify devices though distribution and use. System requirements are being phased in over seven years according to established compliance dates based primarily
Drugs
FDA is delaying the effective date of portions of a final rule that would have revised the agency’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended use. Comments to FDA from stakeholders complained that the proposed changes were not
Drugs
Public Citizen is questioning FDA’s delay in banning from the market all hydroxyethyl starch (HES) intravenous (IV) solutions, a move the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended 1/12. Last year, the group petitioned the agency to remove HES IV solutions from the market,
Biologics
FDA has approved a GlaxoSmithKline supplemental BLA for an expanded indication for Fluarix Quadrivalent (influenza vaccine) to include use in those six months and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in those three years of