Drugs
FDA’s Antimicrobial Drugs Advisory Committee has voted 16-2 to recommend approval for Gilead Sciences’ HIV drug Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for pre-exposure prophylaxis (PrEP) in men and transgender women who have sex with men. Panel members were mixed in
Drugs
Senate Finance Committee chairman Chuck Grassley (R-IA) says FDA should reinstate unannounced inspections of prescription drug manufacturing facilities in foreign countries in light of the administration’s proposed Safe Importation Action Plan and the fact that the foreign facilities provide most of the ingredients for drug production in the
Drugs
FDA has issued a draft guidance, Fabry Disease: Developing Drugs for Treatment, to give sponsors recommendations regarding clinical trial design features that can support approval of drugs and biological products intended to treat Fabry Disease (FD). The document says FD is a rare, X-linked, slowly progressive, lysosomal storage disorder
Drugs
The CDER Office of Prescription Drug Promotion is proposing research to determine healthcare providers’ awareness, perceptions, and beliefs about the benefits and risks of an FDA-approved product that carries a Boxed Warning. A Federal Register notice says Boxed Warning information may be included as part of prescribing information at
FDA Policy/General
A CMI Media survey of 127 doctors across 25 specialties looked at what information providers find most engaging and how they most prefer to receive it. The online report says that over 99% of healthcare providers who responded say they find medical reprints useful. One of the most effective tools
FDA Policy/General
Federal Register notice: FDA has made available an annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” FDA is required to report annually on the status of postmarketing requirements and postmarketing commitments agreed upon by application holders of approved drug and
FDA Policy/General
Federal Register notice: FDA has revoked an Emergency Use Authorization issued to InBios International for the ZIKV Detect 2.0 IgM Capture ELISA based on the company gaining de novo marketing clearance 5/23 for the Class 2 device under the generic name “Zika virus serological reagents.” To view the
FDA Policy/General
Federal Register notice: FDA has filed with the Library of Congress an annual report on agency advisory committees that held closed meetings during fiscal year 2018. The report is mandated by the Federal Advisory Committee Act. To view the notice, click here.
Devices
FDA says that because of ongoing concerns about a late mortality signal in patients treated for peripheral artery disease in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents, it is working with manufacturers working on updated device labeling and clinical trial informed consent documents. In an 8/
Drugs
FDA is funding a 9/17 meeting hosted by The Critical Path Institute and the National Organization for Rare Disorders (NORD) to formally launch development of a new rare disease data and analytics platform. The host organizations say the platform’s goal is to accelerate movement of therapies from bench
Devices
FDA has cleared a NinePoint Medical for the NvisionVLE Imaging System for use in the pancreas and bile duct. These anatomical indications add to the existing esophageal applications for NinePoint’s optical coherence tomography imaging platform. The device provides physicians “real-time, high-resolution volumetric images of the tissue surface
Drugs
The Government Accountability Office (GAO) says FDA should take additional steps to address factors that may affect approval rates of generic drugs in the first review cycle. A GAO report says that 12% of the 2,030 generic drug applications reviewed by FDA from FY 2015 through FY 2017 were
Drugs
FDA has accepted for priority review a Blueprint Medicines NDA for avapritinib for treating adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, and fourth-line GIST. The agency set a user fee review action target of 2/14/2020. Avapritinib is an investigational,
Devices
FDA has issued a Request for Information (RFI) to identify potential parties capable of providing computational human heart modeling software and services to conduct simulations and studies. The RFI says the CDRH Division of Applied Mechanics in the Office of Science and Engineering wants to identify vendors with the capability
FDA Policy/General
Federal Register notice: FDA is seeking interested industry organizations to participate in selecting a nonvoting industry representative to serve on CBER’s Vaccines and Related Biological Products Advisory Committee. FDA is also requesting nominations for a nonvoting industry representative to serve on the advisory committee. A nominee may either be
FDA Policy/General
Federal Register notice: FDA has published a list of seven information collections that have been recently approved by OMB. They are: 1. FDA Adverse Event and Products Experience Reports; Electronic Submissions 2. Investigation of Consumer Perceptions of Expressed Modified Risk Claims 3. Food Labeling: Notification Procedures for Statements on Dietary
Drugs
FDA has accepted for review an Alnylam Pharmaceuticals NDA for givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for treating acute hepatic porphyria. The agency has granted a priority review and set a 2/4/2020 user fee review action target date. Givosiran is intended to lower
Drugs
The FDA annual report on drug and biologic postmarketing requirements (PMRs) and postmarketing commitments (PMCs) for FY 2018 shows that as of 9/30/18 there were 318 unique applicants with open PMRs/PMCs under 755 unique NDAs and BLAs. In the previous fiscal year, there were 299 unique applicants
Drugs
FDA has accepted a Rockwell Medical NDA an intravenous formulation of Triferic (ferric pyrophosphate citrate) for patients with end-stage renal disease and chronic kidney disease. FDA has set a user fee review target action date of 3/28/2020. In May, the company launched the first product from its
Devices
FDA has cleared a Mt. Derm 510(k) to expand the use of its Exceed microneedling device for treating acne scarring. Previously, the device was cleared for treating facial wrinkles. The new clearance was based on data from a clinical study that evaluated the device’s efficacy and safety when
Drugs
A 12/3-12/18/18 FDA inspection at Results RNA, Orem, UT, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/29 Warning Letter says specific violations were: * the firm’s quality control unit failed to exercise its responsibility to ensure drug products
Drugs
FDA says it is pleased that a DC federal court upheld the agency’s interpretation regarding the bulk substances that may be used by outsourcing facilities in drug compounding. An agency statement says FDA previously announced that vasopressin is not a bulk drug substance for which there is a clinical