Biologics
FDA commissioner Stephen Hahn and CBER director Peter Marks say the available data “continue to support the use of two specified doses of each authorized [Covid-19] vaccine at specified intervals.” Hahn and Marks issued a joint statement to counter mass media articles and opinion pieces, such as this one
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Coco’s Holistic Specialties & Apothecary (1/4): FDA recently reviewed the firm’s Web site (https://cocosholisticspecialties.org) and determined that it is marketing unapproved and misbranded products
Devices
FDA has published a guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, with an overview of the mechanisms available to submitters to request feedback from or a meeting with FDA on various types of potential or planned medical device submissions. The document says the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300” (OMB Control Number 0910-0633). To view the notice, click here.
Drugs
FDA has published a draft guidance, Human Gene Therapy for Neurodegenerative Diseases, with recommendations for sponsors developing human gene therapy products for neurodegenerative diseases affecting adult and pediatric patients. The document defines neurogenerative diseases as a heterogeneous group of disorders characterized by progressive degeneration of the structure and function of
Drugs
FDA has lifted its partial hold on a Marker Therapeutics Phase 2 trial investigating the safety and efficacy of MAT-401, the company’s lead multi-tumor-associated antigen-specific T cell product candidate for treating post-transplant acute myeloid leukemia (AML). The company says the trial is evaluating the
Drugs
FDA says its review of a Web site and Facebook site maintained by Reddy Naturals, Kennesaw, GA, indicated that the company is selling several products that are considered unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. A 12/18 Warning Letter quotes extensively from the company Web
Drugs
FDA has released the FDA-483 issued following a 3/16-3/20/20 inspection at OSO Biopharmaceuticals Manufacturing, an Albuquerque, NM, parenteral drug manufacturer. The two inspection observations were: * failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and * failure of written
Drugs
Bristol-Myers Squibb is shutting down its Opdivo (nivolumab) program to use the immuno-onology drug in treating newly-diagnosed brain cancer patients. Endpoints News reports that Opdivo plus standard-of-care temozolomide (Merck’s Temodar) plus radiation performed no better than placebo in extending overall survival in patients with
Drugs
HHS and the Defense Department have signed a $356 million contract with Merck for between 60,000 and 100,000 doses of its MK-7110, an immune system modifying antibody that the company recently acquired in its buyout of OncoImmune. The doses would be produced by this June. The administration
Drugs
Attorney Joanne Hawana (Mintz) says the most important thing FDA did in authorizing two mRNA Covid-19 vaccines at the end of 2020 was to be as transparent as possible. Writing in an online year-end review of FDA’s Covid drug and biologic activities, Hawana says the publicly available
Drugs
FDA has approved Amphastar Pharmaceuticals’ generic glucagon for injection, 1mg/vial packaged in an emergency kit, for treating severe hypoglycemia that may occur in patients with diabetes. An agency statement says the drug also is indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel,
Devices
FDA has authorized the marketing of Interscope’s EndoRotor system to resect and remove necrotic tissue for patients with walled-off pancreatic necrosis. An agency statement says the system includes a power console, foot control, specimen trap, and single-use catheter, and is used in a direct endoscopic necrosectomy. The
Drugs
FDA has sent Warning Letters to five companies selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. An agency notice says that the letters address illegal marketing of unapproved CBD products claiming to treat medical conditions. They include products that are especially concerning
Devices
FDA has published a guidance, Product Labeling for Laparoscopic Power Morcellators, with recommendations on the content and format for certain labeling information for laparoscopic power morcellators (LPM). The document says the recommendations reflect the state of the science and available technology regarding the use of LPMs and are being made
Drugs
FDA says its testing of Herbacil Antiseptic Hand Sanitizer produced by Broncolin, Iztacalco, Mexico, found that the product is adulterated and misbranded. A 12/21 Warning Letter says agency laboratory testing determined that the product contained large amounts of methanol, even though it was labeled to contain ethanol. The letter
Drugs
FDA says Sunstar Americas has expanded its nationwide recall of Paroex chlorhexidine gluconate oral rinse 0.12% due to microbial contamination. The expanded recall covers products bearing an expiration date from 12/31/20 to 9/30/22, according to an agency notice. The notice says the product may be
Devices
FDA says the Cook Medical 11/24/20 recall of Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers is Class 1. An agency notice says the two products are catheters that have a coated shaft, a valve, a dilator, and markers that show on an x-ray.
Drugs
FDA has approved Ridgeback Biotherapeutics’ Ebanga (ansuvimab-zykl), a human monoclonal antibody, to treat Zaire ebolavirus infection in adults and children. An agency notice says Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell. The agency says that Zaire ebolavirus is one of
Drugs
FDA says it has taken steps to strengthen the Risk Evaluation and Mitigation Strategies (REMS) program for transmucosal immediate-release fentanyl (TIRF) products to help ensure that the drugs’ benefits continue to outweigh their risks. An agency statement says that despite the decline in the use of TIRF products in
Drugs
FDA has published a guidance, Providing Regulatory Submissions in Electronic Format—Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling, to describe the format requirements for the electronic submission of the content of a risk evaluation and mitigation strategy (REMS) document under section 745A(a) of
Drugs
FDA has published a guidance, Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment is Needed During the Covid-19 Public Health Emergency, with information on review timelines the agency will use during the Covid-19 public health emergency. The document applies to applicant responses to