FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. ForYou, Inc., Loris, SC (10/20): FDA inspected the firm 2/19-2/21 and found significant GMP violations for dietary supplements, among other citations. The agency says that
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 10/13 notice announcing a public meeting and requesting comments on a potential revised approach for considering the human medical importance of antimicrobial new animal drugs when assessing and managing the antimicrobial resistance risks associated with their use in
FDA Policy/General
Federal Register notice: FDA has made available a final guidance for industry #242 entitled In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products. In-use stability testing is intended to establish a period of time during which a multiple-dose drug product may be
Drugs
FDA has made available a draft guidance on Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications. The document notes that elevated gastric pH by acid-reducing agents (ARAs) can affect the solubility and dissolution characteristics of ora lly administered drug
FDA Policy/General
Federal Register notice: FDA has issued an order permanently debarring Barry J. Cadden from providing services in any capacity to a person that has an approved or pending drug product application. In 2017, Cadden was convicted on three counts of introduction of misbranded drugs into interstate commerce, among other charges,
Drugs
FDA has approved a Rhythm Pharmaceutical NDA for Imcivree (setmelanotide) for chronic weight management (weight loss and weight maintenance for at least one year) in patients six years and older with obesity due to three rare genetic conditions: pro-opiomelanocortin (POMC) deficiency, proprotein subtilisin/kexin type 1 (PCSK1) deficiency, and
Drugs
FDA has launched the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for novel drug development tool (DDT) developers. “ISTAND encourages development of DDTs that fall outside of the existing DDT qualification programs: biomarkers, clinical outcome assessments, and animal models for use under the Animal Rule,” an
Biologics
Moderna has filed an emergency use authorization (EUA) for its Covid-19 vaccine mRNA-1273 based on updated efficacy data showing 94.1% vaccine efficacy. The vaccine’s primary efficacy analysis was based on 196 Covid cases, of which 185 were observed in the placebo group versus 11 in the
Devices
FDA has approved a Profound Medical humanitarian device exemption to market Sonalleve for treating osteoid osteoma, a non-cancerous bone tumor that occurs most often in the long bones of the leg, such as the femur and tibia, of young children and adolescents. The condition causes a dull, aching pain
FDA Policy/General
Info Collection on Dietary Supplement GMPs Federal Register notice: FDA sends to OMB an information collection revision entitled “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.” 11/25/2020 Info Collection on Special Protocols Federal Register notice: FDA submits to
FDA Policy/General
Celgene has agreed to acquire Delinia Inc., a privately held biotechnology company developing novel therapeutics for autoimmune disease.The $300 million transaction expands Celgene’s inflammation and immunology pipeline through the acquisition of Delinia’s lead program, DEL106, a novel IL-2 mutein Fc fusion protein . The therapy is designed
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Qualification Process for Drug Development Tools. The process was mandated in the 21st Century Cures Act, which defined a three-stage qualification process for drug development tools. The guidance outlines the new qualification process and transparency requirements, and discusses
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA. The document describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) an ANDA for a
Devices
FDA has updated a guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the Covid-19 Public Health Emergency, to further assist manufacturers in providing the agency with timely and informative notifications about changes in
Devices
Two Massachusetts Eye and Ear Hospital doctors say FDA should use the 510(k) pathway to clear over-the-counter hearing aids. Writing in a Perspective column in the New England Journal of Medicine, the doctors say the agency has missed its legislatively-mandated deadline to release rules governing over-
Devices
FDA has cleared a CorticoMetrics 510(k) for Thinq, its artificial intelligence-based software for use by radiologists and neurologists to provide quantitative information to augment patient assessment for a number of neurological disorders and conditions. The device reports volumetric measurements and visualizations of 30 critical brain structures, and compares
Drugs
FDA has approved an Eiger BioPharmaceuticals NDA for Zokinvy (lonafarnib) for treating Hutchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies. The ultra-rare, genetic, premature aging diseases accelerate mortality in young patients, according to the company. Untreated children with Progeria die of heart disease at an average age of
Devices
FDA has issued an immediately-in-effect guidance, Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus 2019 (Covid-19) Public Health Emergency, saying that the agency does not intend to object to using dry heat systems
Biologics
FDA has deferred its review decision on a Revance Therapeutics BLA for daxibotulinumtoxinA for injection, an investigational neuromodulator for treating moderate to severe glabellar (frown) lines. The agency said a required inspection could not be conducted at the company’s northern California manufacturing facility due travel restrictions associated with the
Drugs
Purdue Pharma pleaded guilty in New Jersey federal court 11/24 to conspiracies to defraud the United States and violate the anti-kickback law. It previously had agreed to the imposition of the largest penalties ever levied against a drug company. The Department of Justice says the company pleaded guilty
Biologics
Merck has submitted BLA for V114, an investigational 15-valent pneumococcal conjugate vaccine for use in adults 18 years of age and older. The submission is based on data from Phase 2 and Phase 3 clinical studies in healthy adults and those at increased risk, such as adults with chronic
FDA Policy/General
Three Covington & Burling attorneys say a stronger regulatory focus can be expected at FDA in the administration of president-elect Joe Biden. In an online post, the attorneys outline their expectations by Center and program. CBER and CDER * additional effort to promote generic and biosimilar competition; * supply chain and