Drugs
An unexpected safety signal has led Takeda Pharmaceutical Co. to halt two Phase 2 studies of TAK-994, an investigational oral orexin agonist for treating narcolepsy. Without providing any details of the safety concern, Takeda says that stopping the trials “allows for the timely interpretation of the benefit/risk profile
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs. The document describes FDA’s current thinking on incorporating complex adaptive and other novel investigation designs into proposed clinical investigation protocols and applications for new animal drugs.
FDA Policy/General
Center for Veterinary Medicine (CVM) director Steven Solomon says FDA has released four final guidances describing pathways for animal drug sponsors to use new approaches like adaptive study designs, real-world evidence, and biomarkers to establish drug effectiveness. The documents also offer more detailed guidance on how to leverage data
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals. The International Council for Harmonization document expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach that is not described in
Devices
FDA says it has learned that Marci Beauty, Spring Valley, NV, is selling seven light therapy devices without marketing clearance or approval. A just-released 2/2 Warning Letter says the products are legally regulated as medical devices because they are intended for use in the diagnosis of disease or
Devices
FDA has classified as Class 1 a Medtronic recall of certain insulin pumps that was initiated to replace any pump that has a clear retainer ring with one that has the updated black retainer ring. Medtronic previously told customers about missing or broken clear retainer rings in the MiniMed 630G
Drugs
Former FDA human factors team leader Shannon Hoste has been named president of Agilis Consulting, which describes itself as a full-service medical human factors firm. Agilis says Hoste provided oversight to hundreds of human factors submissions to CDRH and CDER, making her a recognized expert in risk management and
Drugs
A study by University of Maryland School of Business risk management expert Clifford Rossi, funded by FDA and HHS, has identified a combination of factors that he says makes pharmaceutical production in the U.S. more attractive now than investing in either China or India. Rossi says that adopting advanced
Biologics
Johnson & Johnson has submitted data to support an emergency use authorization for its Covid-19 booster shot in those 18 years of age and older. The filing, according to the company, includes data from the Phase 3 ENSEMBLE 2 study that found a booster given 56 days after the
Drugs
FDA has revised four guidance documents based on a final rule on the medical device de novo classification process. For example, the guidance Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff provides further detail about the types of information FDA believes are
Drugs
AstraZeneca is asking FDA for an emergency use authorization (EUA) for its AZD7442 long-acting antibody (LAAB) combination for prophylaxis of symptomatic Covid-19. The company says that if FDA approves the EUA, it would be the first LAAB to receive an EUA for Covid-19 prevention. The AZ statement
Devices
FDA says Medtronic expanded its Class 1 recall of all MiniMed remote controllers used with a Medtronic MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to cybersecurity risks. Some 31,310 recalled units were distributed between 8/1999 and 7/2018. The company initiated the
Drugs
FDA says the Covid-19 pandemic has reinforced the need to adopt and accelerate the implementation of ways to increase critical supplies and supply chain resilience. An online Advanced Manufacturing update says advanced and smart manufacturing technologies have been identified as potential ways to meet the needs. The update cites
FDA Policy/General
Federal Register notice: FDA is withdrawing a 9/30 notice that announced in error the issuance of a priority review voucher to a rare pediatric disease product sponsor. In the withdrawn notice, the agency wrongly determined that a Enzyvant Therapeutics BLA Rethymic (allogeneic processed thymus tissue-agdc) met criteria for
FDA Policy/General
Federal Register notice: FDA has updated its listing of available guidance documents related to the Covid-19 public health emergency. Periodic updates are pursuant to the process that FDA announced 3/2020 for making guidances available during the pandemic. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced an 11/19 public workshop entitled “Best Practices for Development and Application of Disease Progression Models.” The workshop is intended to discuss the best practices for developing disease progression models and their application to support drug development decisions. It will also share case studies
Drugs
Recent appeals court decisions against FDA in orphan drug cases will “force FDA to take a hard look at this approach to orphan drug designations, as it may find it difficult to develop a consistent rubric for evaluating orphan drug designation requests.” That’s the view of attorneys Sara Koblitz
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 6/25 Federal Register and announced the approval withdrawal of 36 ANDAs from multiple applicants. Yung Shin Pharmaceutical subsequently notified the agency about not withdrawing ANDA 065152, cephalexin capsules, and this notice states its approval is still in
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities” (OMB Control Number 0910-0883). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Electronic User Fee Payment Request Forms — Form FDA 3913 and Form FDA 3914 (OMB Control Number 0910-0805). Form FDA 3913, User Fee Payment Refund Request, is designed to provide information for FDA to review and process
Drugs
Three generic drug makers — Taro Pharmaceuticals, Sandoz and Apotex —have agreed to pay $447 million to resolve alleged False Claims Act violations related to price fixing conspiracies involving various generic drugs. The Justice Department alleges that between 2013 and 2015, the companies paid and received compensation prohibited by the Anti-
Devices
A new FDA final rule on the medical device de novo marketing pathway has modified earlier language contained in the proposed rule to now permit manufacturing inspections in limited scenarios. The rule establishes procedures and criteria for submitting a de novo request, which can occur after a device sponsor receives