Devices
FDA has issued a safety alert to warn patients and health care providers about patient injuries from wearing face masks that contain metal parts and coatings during a Magnetic Resonance Imaging (MRI) exam. “Metal parts, like nose pieces sometimes called nose clips or wires, nanoparticles (ultrafine particles), or antimicrobial coating
Drugs
FDA is detailing the launch of a new pilot program to provide a pathway for novel drug development tools (DDTs) to be used in regulatory applications for new medical products. The program, Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program, is intended to streamline and potentially speed
FDA Policy/General
President-elect Joe Biden has selected California attorney general Xavier Becerra as his nominee for HHS secretary. Becerra has served almost four years as the state’s chief law enforcement officer. Previously, he served 12 terms in Congress as a member of the U.S. House of Representatives. While in
FDA Policy/General
Federal Register notice: FDA is announcing the revocations of Emergency Use Authorizations (EUAs) issued to manufacturers of certain protective barrier enclosures and to manufacturers of certain infusion pumps and accessories. FDA revoked the protective barrier enclosures EUA on 8/20 after becoming aware of new preliminary evidence from simulated intubation
Drugs
Expanding on previous direct-to-consumer (DTC) advertising research involving celebrities and other endorsers used in advertisements, CDER’s Office of Prescription Drug Promotion (OPDP) is proposing to examine four types of endorsers (celebrity, physician, patient, non-celebrity influencer) in two separate studies. The studies plan to examine whether the
Devices
CDRH’s user fee commitments are being negatively impacted by the Center’s top-priority Covid-19 work, director Jeff Shuren told a 12/3 Alliance for a Stronger FDA Webinar. Since the beginning of the Covid-19 emergency, the Center has accepted over 5,000 feedback requests related to
Drugs
FDA has added content to a question-and-answer appendix in its guidance titled Conduct of Clinical Trials of Medical Products During Covid-19 Public Health Emergency. The updated document’s added question pertains to considerations for disposing unused investigational drug products when a study participant cannot return it to
Devices
FDA has updated its 2019 safety communication on Endologix’s AFX endovascular graft systems used in treating abdominal aortic aneurysms (AAA) and the risks associated with Type III endoleaks with the devices. It is reminding patients and health care providers of the importance of at least yearly, lifelong follow-up
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Requesting FDA Feedback on Combination Products. The document discusses ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and describes best practices for FDA and sponsors when interacting on such topics. To
Devices
FDA has cleared an Ensemble Orthopedics 510(k) for its Ensemble CMC Implant for treating patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint. The device features a proprietary saddle shape that “replaces the natural bearing surfaces of the carpal and metacarpal bones with an interpositional implant that allows
Drugs
FDA has approved labeling changes stating that Merck’s Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (sitagliptin and metformin hydrochloride extended-release) are not proven to improve glycemic (blood sugar) control in pediatric patients age 10 to 17 with Type 2 diabetes . The drugs are approved to
FDA Policy/General
Federal Register notice: FDA has corrected an 11/25 notice on a guidance entitled Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments. The notice was published with incorrect information in the Paperwork Reduction Act of
Drugs
Responding to an FDA draft guidance on developing drugs and biologics for adjuvant treatment of bladder cancer, Novartis says it applauds the agency’s efforts to seek input from stakeholders on actionable policy suggestions that could be implemented in the near-term by CDER Office of New Drugs staff to
Drugs
In a suit filed in a Maryland federal court, Genus Lifesciences says that Lannett Company made untrue statements to FDA in an NDA for its Numbrino, a cocaine-based anesthetic, and the agency has not performed its legal duty to withdraw approval of the NDA. The suit acknowledges that Genus
FDA Policy/General
Speculation is growing as to who will be selected as FDA commissioner under the incoming Biden Administration, and two familiar names are circulating the rumor mill. Former commissioner David Kessler (11/8/1990 to 2/28/1997) and former principal deputy commissioner Joshua Sharfstein (2009–2011) are reportedly top contenders.
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Pharmacy Compounding Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/25/2022. To view the notice, click here.
FDA Policy/General
Research!America and 75 other organizations have contacted Senate majority leader Mitch McConnell (R-KY) and House Speaker Nancy Pelosi (D-CA) to urge that Congress address two national imperatives: * approval of an FY 21 appropriations package that includes increased funding for Covid-relevant and strategically pivotal agencies such as
Devices
FDA says it is prioritizing the review of emergency use authorization (EUA) requests for Covid-19 tests based on factors such as the public health need for the product and product availability. An update to the Frequently Asked Questions related to Covid-19 test development and review says the agency
Drugs
FDA says that MPM Medical, Mesquite, TX, is recalling one lot of Regenecare HA Hydrogel due to contamination with the bacteria Burkholderia cepecia. An agency notice says Regenecare HA Hydrogel is an over-the-counter product containing 2% lidocaine that is used topically for temporary relief of pain and itching
Biologics
Former CBER Division of Manufacturing and Product Quality reviewer and investigator John Godshalk has joined NDA Partners as an expert consultant. An NDA announcement says Godshalk is an expert in chemistry, manufacturing, and controls, quality, and facility issues for cell and gene therapies, and has experience with biologics, vaccines, drugs,
Devices
FDA has cleared a Viveve Medical 510(k) to expand its manufacturing capacity for its consumable treatment tips used with the company’s Cryogen-cooled Monopolar Radiofrequency (CMRF) technology. CMRF is used with the Viveve System, which is indicated for use in general surgical procedures for electrocoagulation and hemostasis. Viveve
Biologics
Janssen Pharmaceutical has submitted a BLA for amivantamab for treating patients with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody