Drugs
JAMA deputy editor Gregory Curfman says it is “troublesome” that in most jurisdictions, both generic and innovator drug companies are protected from legal liability stemming from failure-to-warn claims. “Congress should fully consider this issue and fill the gap in the current legal framework through legislation,” he writes in
Devices
FDA has cleared a Techlab 510(k) for the H. Pylori Quik Chek and the H. Pylori Chek tests that are intended to aid in diagnosing H. pylori infection. Quik Chek is a rapid diagnostic test that detects H. pylori in 30 minutes, whereas the Chek test is a 96-
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hangzhou Karic Commodities Hangzhou, China (7/31): FDA inspected the firm in March and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for
Devices
FDA has cleared a UVision360 510(k) for the Luminelle DTx Hysteroscopy for use in both hysteroscopy and cystoscopy procedures. The device allows physicians to see the uterus’ internal lining from an “optimal distance with clarity thus enabling identification of suspicious tissue, perform a biopsy under visualization, and offer a
Drugs
FDA has granted Audentes Therapeutics a regenerative medicine advanced therapy (RMAT) designation for AT132 and its use in treating X-linked myotubular myopathy. The RMAT designation was granted based on positive interim clinical data from ASPIRO, an ongoing Phase 1/2 clinical study. The data, according to the company, showed
Drugs
FDA has approved a Merck expanded label for Keytruda in combination with pemetrexed (Alimta) and platinum chemotherapy for first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. The approval was based on results of the KEYNOTE-189
Devices
bioMerieux has recalled its Vitek 2 AST P631 after customer reports indicate an increase in the rate of non-detected methicillin-resistant Staphylococcus aureus. The automated system comprises instruments, software and reagent cards designed for antimicrobial susceptibility testing of bacteria and yeast.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level” (OMB Control Number 0910–0430). The information collection involves the process for formally resolving scientific and procedural disputes in FDA’s CDER and CBER that
FDA Policy/General
Federal Register notice: FDA has announced a 9/20 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. To view the notice, click here.
Drugs
FDA has posted a guidance on “Quality Attribute Considerations for Chewable Tablets” that provides the agency’s current thinking on the critical quality attributes that should be assessed during the development of such products. It also provides recommendations for sponsors/applicants regarding the submission of developmental, manufacturing, and labeling information
Drugs
FDA has posted a guidance on “Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.” The document is intended to assist sponsors regarding nonclinical studies recommended to support human clinical trials and marketing applications. It discusses how to refine nonclinical study recommendations for this class of drug given its unique characteristics ( e.
FDA Policy/General
Federal Register notice: FDA has extended the comment period for a previous notice about study designs intended to generate data to support substantial evidence of effectiveness for investigational new animal drugs intended for preventing heartworm disease in dogs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Samples and Protocols” (OMB Control Number 0910–0206). The collection supports FDA’s authority to require manufacturers of licensed biological products to submit to FDA samples of any lot along with the protocols showing the results of
FDA Policy/General
Federal Register notice: FDA has announced a 9/27 Neurological Devices Panel meeting to review a Sequent Medical PMA for the Woven Endobridge (WEB) Aneurysm Embolization System, which is intended to treat wide-neck intracranial aneurysms arising or located at a vessel bifurcation. The WEB device is being evaluated in
FDA Policy/General
Quality Metrics Proposal Period Extended Federal Register notice: FDA extends the proposal period for its “Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff” to allow interested persons additional time to submit a proposal. 08/17/2018 Info Collection
Devices
An FDA review of a post-approval study conducted by SynCardia Systems for its Temporary Total Artificial Heart Companion 2 Driver System (C2 Driver System) has shown a higher mortality rate and higher stroke rate for patients initially supported with the device compared to patients initially supported with the previous
FDA Policy/General
Federal Register notice: FDA has extended the proposal period for its “Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff” to allow interested persons additional time to submit a proposal. Proposals are being accepted until 12/17. To view
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Guidance for Industry: Controlled Correspondence Related to Generic Drug Development.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has granted an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. The Voluntary Malfunction Summary Reporting Program is mandated by the recent device user fee reauthorization agreement to streamline malfunction reporting. To view the
FDA Policy/General
Federal Register notice: FDA has identified a list of device accessories for which it believes general controls are sufficient to provide reasonable assurance of safety and effectiveness. The notice proposes to classify the accessories into Class 1, and it seeks comments on the actions. To view the notice, click here.
Drugs
FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, and finished drug manufacturers that Sichuan Friendly Pharmaceutical Co. Limited (China) has recalled certain lots of porcine thyroid API due to inconsistent quality of the API. FDA recommends that manufacturers and compounders not use this API received since 8/2015.
Devices
FDA has granted Brainsway de novo marketing clearance for its Deep Transcranial Magnetic Stimulation System for treating obsessive compulsive disorder (OCD). The device uses magnetic fields to stimulate nerve cells in the brain. It was originally cleared in 2008 for treating major depression, and in 2013 it was cleared for