Drugs
In separate amicus briefs, Mylan and the Generic Pharmaceutical Association’s Biosimilars Council have asked the Supreme Court to hear Apotex’ appeal of a lower court decision in its case against Amgen involving provisions of the 2009 Biologics Price Competition and Innovation Act. Apotex has asked the high court to
FDA Policy/General
Federal Register Notice: FDA is seeking comments on a planned direct-to-consumer (DTC) advertising study that has been submitted to OMB for approval. The research will examine the growing use of animation in prescription drug advertising and promotional activities and whether such use minimizes risk or inflates efficacy perceptions.
FDA Policy/General
Federal Register Notice: FDA has announced a 12/5 public workshop on “The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance.” The workshop is designed to explore the critical role of hospitals in the evolution of medical device surveillance and in creating
Drugs
A 10/12-10/16/15 FDA inspection at Interpharm, Modrany, Czech Republic, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API) and significant CGMP violations for finished pharmaceuticals, according to a 10/18 Warning Letter. Specific deviations and violations included: * failing to prevent unauthorized
Drugs
Significant violations of current good manufacturing practice regulations for finished pharmaceuticals were found during a 1/21-1/29 FDA inspection at Teva’s drug manufacturing facility in Godollo, Hungary. A 10/13 Warning Letter says that specific violations included: * failing to thoroughly investigate any unexplained discrepancy or failure of
FDA Policy/General
Buderer Drug Company, Inc. Perrysburg, OH (9/20). FDA inspected the firm in January and documented that it was not receiving valid prescriptions for individually-identified patients for compounded drugs. In addition, an agency investigator observed serious deficiencies in the firm’s practices for producing sterile drug products. For example,
Devices
St. Jude Medical has recalled certain models of its Fortify, Unify, and Assura implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) due to reports of rapid battery failure caused by deposits of lithium (lithium clusters) forming within the battery, and causing a short circuit. “If the battery
Drugs
Several drug manufacturers are asking FDA for additional information on a draft guidance on clinical trial endpoints for ulcerative colitis. GlaxoSmithKline says the draft lacks guidance for sponsors on the desired definition of clinical response in the context of the proposed use of a modified Mayo score. “While the guidance
Drugs
FDA has approved a class-wide labeling change for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids
Drugs
Metabolic Therapy, Austin, TX, has submitted a citizen petition asking that FDA amend the OTC External Analgesic Drug Products monograph for active ingredients to indicate that melatonin and inositol hexaphosphate are safe and effective for external analgesic drug products. The petition says the monograph should indicate that topical external analgesic
Drugs
FDA has approved a Merck supplemental NDA for Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score of 50% or more)
Drugs
FDA has released a draft guidance on “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment” that is intended to assist sponsors in developing such drugs. The document addresses the agency’s current thinking regarding the overall clinical development program, with a focus on Phase 3
Devices
The Yale Collaboration for Research Integrity & Transparency says it supports appropriate use of high quality real-world evidence in the context of post-market medical device regulation and surveillance. Commenting on an FDA draft guidance, on using real-world evidence to support medical device regulatory decision-making, the group
Devices
FDA says that Viracor-IBT Laboratories, Lee’s Summit, MO, is distributing a Zika Virus IgG test and Zika Virus IgG and IgM Panel without marketing clearance, approval, or authorization from the agency. A 10/21 untitled letter says that the agency issued an emergency use authorization for the firm’
Devices
AdvaMed says it appreciates FDA’s interest in providing guidance and further clarity regarding the form and content of a device’s unique device identifier (UDI). In comments on the agency’s draft guidance on the form and content of a UDI, the association says it does not agree that
FDA Policy/General
Federal Register Notice: FDA and CMS have announced their intention to fully implement their joint “parallel review” pilot program. Parallel reviews allow both agencies to review information about a medical device concurrently, rather than sequentially, while continuing to make their premarket review and coverage decisions consistent with their respective statutory
Devices
CDRH wants to improve medical device post-market data by improving hospital (user) reporting of adverse events. Following high-profile device safety issues occurring in hospitals in 2015, such as the spread of uterine cancer from the use of morcellators or the spread of infections associated with contaminated duodenoscopes, FDA
Drugs
FDA is advancing a planned direct-to-consumer (DTC) advertising study by seeking OMB approval to research the growing use of animation in prescription drug advertising and promotional activities and whether such use minimizes risk or inflates efficacy perceptions. A just-posted notice seeks comments on the proposed research that
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection related to “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans.” The document clarifies agency expectations for
Drugs
FDA has placed a clinical hold on an Inovio Pharmaceuticals proposed Phase 3 clinical program for VGX-3100, requesting additional data to support the shelf-life of the newly designed and manufactured disposable parts of the Cellectra 5PSP immunotherapy delivery device. The company says it is working with the agency
FDA Policy/General
Federal Register Notice: FDA has corrected a 9/26 notice announcing a public meeting to discuss proposed recommendations for reauthorizing the Generic Drug User Fee Amendments of 2012. On page 66038, in the final paragraph of the first column, the second sentence is corrected to read: “Specifically, FDA would issue
FDA Policy/General
Federal Register Final Order: FDA has classified the Eustachian tube balloon dilation system into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the device. To view the order, click here.