Devices
A Bayer official warned the company of increased FDA scrutiny of injuries from its Essure implanted contraceptive device before it was withdrawn from the market, according to recently unsealed court documents reported by Bloomberg News. The news service reports that a company product surveillance senior manager said in an internal
Drugs
FDA has approved a Novartis NDA for Kesimpta (ofatumumab) for subcutaneous use to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The drug is described as a targeted, precisely dosed and delivered B-cell therapy that can be self-
Devices
FDA has updated its alert on breast implant adverse events to include new reports received through 1/5. An updated table on the agency’s breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) Web page now includes a total of 733 unique cases and 36 patient deaths globally, which
Drugs
FDA says it has approved changes to labeling for hydrochlorothiazide (HCTZ) to inform healthcare professionals and patients about a small increased risk of non-melanoma skin cancer associated with HCTZ use. The changes also encourage patients to protect their skin from the sun, an agency notice says. The overall risk
FDA Policy/General
Federal Register notice: FDA has submitted to OMB and information collection extension for “Customer/Partner Service Surveys” (OMB Control Number 0910–0360). FDA intends to use the information from the surveys to identify strengths and weaknesses in service to customers/partners and to make improvements. They will measure timeliness, appropriateness
Drugs
FDA has approved a Janssen Biotech supplemental BLA for the use of Darzalex (daratumumab) in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for relapsed/refractory multiple myeloma in those who have received one to three previous therapies. Approval was based on data from the Phase 3 CANDOR study that
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c). The document describes FDA’s policy concerning the conditions under which it generally does not intend to take regulatory action against an
FDA Policy/General
Federal Register notice: FDA has issued a stay of regulatory effectiveness provisions banning electrical stimulation device use on certain self-injurious or aggressive behavior individuals. FDA is publishing the notice in response to petitions for an administrative stay of action in accordance with regulatory requirements. To view the notice, click
Drugs
The dietary supplement industry reportedly is concerned about recent Warning Letters to several dietary supplement manufacturers that said N-acetylcysteine (NAC) is excluded from the definition of a dietary supplement because it was first approved as a drug in 1963. Natural Products Insider says in an online post that the
Biologics
FDA says Web sites and social media posts for Predictive Biotech, Salt Lake City, UT, promote sales of CoreCyte, an umbilical cord-derived product, to mitigate, prevent, treat, diagnose, or cure Covid-19. An 8/17 Warning Letter says CoteCyte is a human cell, tissue, or cellular or tissue-based
FDA Policy/General
Federal Register notice: FDA has added a statement to the docket of a 2/4 public meeting on “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc” to clarify that a subsequent posted executive summary is not agency recommendations. The agency says the executive summary and related presentations
Drugs
FDA has temporarily put the brakes on an emergency use authorization (EUA) for using blood plasma therapy for treating Covid-19 patients until more data are presented to demonstrate its effectiveness, according to several media reports. NIH director Francis Collins and National Institute of Allergy and Infectious Diseases director Anthony
Drugs
FDA has issued a complete response letter to Gilead Sciences for its NDA for filgotinib to treat moderately to severely active rheumatoid arthritis. The company says the agency requested data from the MANTA and MANTA RAy studies before completing the NDA review. It says the studies are intended to assess
Drugs
FDA has issued an 8/18 complete response letter to BioMarin Pharmaceutical for its valoctocogene roxaparvovec gene therapy for severe hemophilia A. The company says the agency is now requesting two years of data from the ongoing Phase 3 study to provide evidence of a durable effect using annualized bleeding
Drugs
FDA has issued an immediately-in-effect guidance, Manufacturing, Supply Chain, and Drug and Biological Product Inspections During Covid-19 Public Health Emergency Questions and Answers, to provide answers to frequently asked questions about regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for
Drugs
CBER has issued a Manual of Policies and Procedures (MAPP), Consolidation of ANDAs by the Office of Generic Drugs, describing the process for reviewing and approving or denying requests to consolidate previously approved ANDAs submitted by an ANDA applicant. The MAPP applies to the Office of Generic Drugs (OGD) ANDA
Devices
FDA has cleared an IlluminOss Medical 510(k) for its Photodynamic Bone Stabilization System for treating fibula fractures. IlluminOss says the device is a patient-specific intramedullary implant that has a light-curable liquid monomer, contained within an expandable balloon, to create a patient-conforming, rigid implant within the bone
Devices
FDA has cleared a Hyperfine Research 510(k) to expand the use of its portable Swoop MRI imaging device. The point-of-care imaging device can be wheeled to a patient’s bedside, plugs into a standard wall outlet and is controlled through a wireless tablet. Hyperfine says the clearance
Drugs
FDA says Oxford Medical Instruments USA, Carlsbad, CA, is selling through a Web site salt inhaler products intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. An 8/11 Warning Letter says the agency has determined that the products are misbranded unapproved new drugs. “We request that
FDA Policy/General
Federal Register notice: FDA is revising its regulations to reflect changes to the agency’s organizational structure, including the reorganization of the Office of Regulatory Affairs. The revisions update addresses and replace references to the district officials with references to division officials. It does not impose any new regulatory requirements
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Dispute Resolution Procedures for Science-Based Decisions on Products by the Center for Veterinary Medicine — 21 CFR 10.75” (OMB Control Number 0910-0566). The collection supports an agency guidance that describes the process by which CVM
Drugs
FDA has issued a guidance, Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.28(c), related to the retention of reserve samples of the test article and reference standard used in an in vivo bioavailability (BA) and in vivo or in vitro bioequivalence