Drugs
FDA has published a Manual of Policies and Procedures (MAPP), Conversion of ANDA Approval to Tentative Approval Because of Court Order, describing the policies and procedures of the CDER Office of Generic Drugs for converting the approval status of an ANDA from final approval to tentative approval (TA) following a
Drugs
FDA has granted CNS Pharmaceuticals an orphan drug designation for its lead product berubicin for treating malignant gliomas. The designation is partially based on Phase 1 data showing that 44% of patients treated with berubicin demonstrated a significant improvement in progression free survival, and one patient experienced a complete response.
Drugs
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. An agency notice says the drug’s efficacy was investigated in the ATTRACTION-3 trial involving 419 patients. The trial demonstrated a
Drugs
FDA says its review of three Web sites and a Facebook page operated by OutoftheBoxRemedies.com found that the sites are offering iodine products for sale in the U.S. for the mitigation, prevention, treatment, diagnosis, or cure of Covid-19 in people. A 6/10 Warning Letter sent to
Drugs
FDA has approved Pfizer’s Nyvepria (pegfilgrastim-apgf), a biosimilar to Amgen’s Neulasta (pegfilgrastim) for decreasing the incidence of infection as manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive drugs associated with a clinically significant incidence of febrile neutropenia. The company says the approval was
Drugs
FDA and the Federal Trade Commission say that the Web site www.organic-beauty-recipes.com is participating in the Amazon Associates program that pays the site owners a commission for promoting the sale of essential oil products. A 6/8 Warning Letter says the agencies’ review of the Web
Drugs
FDA has approved a Curis IND application for CI-8993, which it describes as the first-in-class monoclonal anti-Vista antibody. A Phase 1a/1b study of CI-8993 is planned for the second half of the year. The multi-center, open-label dose escalation study will evaluate about
Drugs
FDA has cleared a 4Web Medical 510(k) to market its Stand-Alone Anterior Lumbar Interbody Fusion Device. It is designed to allow fixation screws to be placed through the truss implant and into the adjacent vertebral bodies creating a zero-profile stand-alone construct that removes the need for
Drugs
FDA and the National Center for Advancing Translational Sciences at the National Institutes of Health say they have updated the CURE ID app to make it a more effective tool during the Covid-19 public health emergency. A joint statement describes CURE ID as an Internet-based repository that allows
Drugs
University of Minnesota School of Public Health professor Leigh Turner says FDA needs to become much more transparent about the operations of its new Coronavirus Treatment Acceleration Program (CTAP). In an online post at The Conversation, Turner says that “as a specialist in bioethics and public health, I see troubling
Drugs
AbbVie and Genmab have announced a collaboration agreement to jointly develop and commercialize three of Genmab’s early-stage investigational bispecific antibody product candidates and enter into a discovery research collaboration for future differentiated antibody therapeutics for cancer. The companies say they will partner to develop epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-
Drugs
FDA and the U.S. Commerce Department’s National Telecommunications and Information Administration (NTIA) have begun a 120-day pilot to help reduce unapproved opioids illegally offered for sale online. Under the pilot, the agency will notify internet registries that are participating in the pilot – Neustar, Verisign and Public Interest
Drugs
FDA and HealthVerity have entered into a multi-year research collaboration agreement to evaluate a range of different real-world datasets for their potential to inform the agency’s response to Covid-19. Earlier this month, FDA commissioner Stephen Hahn said it is time to look forward and evaluate the
Drugs
FDA has warned the owners of a Web site operating at chloroquineonline.com that they are offering drug products for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19. A 5/18 Warning Letter says such products are legally considered to be
Drugs
Six Hogan Lovells attorneys say the 6/4 FDA update to the Compliance Program Guidance Manual (CPGM) includes a program for inspecting CDER-led and CDRH-led combination products. In an online post, the attorneys write that the updated manual says it “focuses on inspections of combination product manufacturers of
Drugs
Researchers from FDA and several drug companies summarized FDA’s past acceptance of real-world data sources for supporting drug approval in new indications that have been reflected in U.S. labels. Writing in Therapeutic Innovation & Regulatory Science, the researchers say their summary focuses on the type of real-
Drugs
The White House Office of Management and Budget (OMB) reportedly is reviewing an FDA document, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” that industry executives hope represents progress in the agency’s examination of whether and how to regulate the market for CBD (cannabidiol) in dietary supplements
Drugs
Academic researchers from Northwestern University and Smith College say the number of sex-inclusive research studies has significantly increased across most biological disciplines since the National Institutes of Health implemented a 2016 policy requiring investigators to consider sex as a biological variable. Writing in eLife, the researchers say while their
Drugs
FDA is walking back misleading testimony it gave the Senate about U.S. production of active pharmaceutical ingredients (APIs). Late last year, CDER director Janet Woodcock testified before an Energy and Commerce Committee hearing that FDA does not know the volume of APIs being manufactured abroad, but last week CDER
Drugs
The Americans for Homeopathy Choice Foundation is asking FDA to issue a proposed regulation drafted by the foundation on “Homeopathic Drugs and Drugs Labeled ‘Homeopathic.’” The 6/5 petition says the foundation wants FDA to establish regulations that assure consumers that drug products labeled homeopathic are either included in the
Drugs
Senators Mike Braun (R-IN), Lisa Murkowski (R-AK), and Martha McSally (R-AZ) have introduced the Promising Pathway Act (S. 3872) that would establish a rolling, real-time, priority review pathway to evaluate provisional approval applications for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases
Drugs
FDA has granted AlgoTherapeutix an orphan drug designation for ATX01 (topical amitriptyline) for treating erythromelalgia. The rare condition primarily affects the feet and less commonly the hands. It is characterized by intense, burning pain, severe redness and increased skin temperature either episodic or almost continuous. The company says the ATX01