Drugs
FDA has issued two guidances on developing proprietary names for human drug products. One guidance covers prescription drug products and the other covers non-prescription products. The documents say they describe best practices to help minimize proprietary name-related medication errors and otherwise avoid the adoption of proprietary names that
Drugs
The American Civil Liberties Union (ACLU) says the Trump administration has told a federal court that Covid-19 is no longer a serious risk and thus FDA is justified in requiring patients seeking mifepristone to go in-person to a clinical setting solely to sign a form and pick up
Drugs
From 6/2019 to 6/2020, the first full year of the FDA Oncology Center of Excellence’s Project Orbis, the effort received 60 oncology marketing applications for either new molecular entities or supplements adding new indications. Of the 60, 38 were approved. Project Orbis is intended to facilitate oncology
Drugs
FDA has granted Turning Point Therapeutics a breakthrough therapy designation for repotrectinib and its use in treating patients with gene ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have not been treated with a ROS1 tyrosine kinase inhibitor (TKI). The designation was based on positive data from the
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Natures Boost, Kirkland, WA (11/20): A recent FDA review of the company’s Web site determined that it is marketing two unapproved new drugs in violation of the
FDA Policy/General
Federal Register notice: FDA has announced the issuance of a priority review voucher to Y-mAbs Therapeutics related to the approval of Danyelza (naxitamab-gqgk). The agency determined that the product met the criteria for a priority review voucher. It is indicated for use in combination with granulocyte-macrophage colony-
Drugs
FDA says it is testing its capability to receive annotated electrocardiogram (aECG) waveform data in electronic format under the Health Level Seven (HL7) Annotated ECG Waveform Data Standard. Those who are interested in voluntarily testing this capability can submit the aECG files directly through the FDA electronic submissions gateway (ESG)
Drugs
FDA is being criticized for its slow response to the need to find alternatives to physical inspections during the worsening Covid-19 pandemic. The issue is even more critical now as a number of drug submission final review actions have been put on the back burner due to the agency’
Drugs
The Justice Department has filed a civil complaint to stop AMARC Enterprises from distributing unapproved and misbranded drugs and adulterated animal drugs. The company sold and distributed “Poly-MVA” and “Poly-MVA for Pets,” which they claim can cure, mitigate, treat, or prevent disease, including cancer. The complaint also alleges
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