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
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,
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
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
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
FDA Policy/General
Federal Register notice: FDA has ordered the permanent debarment of Michael L. Babich from providing services in any capacity to a person that has an approved or pending drug product application. The order is based on Babich’s recent conviction related to alleged illegal actions in his previous capacity as
FDA Policy/General
Federal Register notice: HHS is announcing its intent to withdraw FDA’s Marketed Unapproved Drugs – Compliance Policy Guide, Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs, and to request information from the public regarding drugs that may be grandfathered or generally recognized as safe and effective. To
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Product Jurisdiction and Combination Products — 21 CFR Part 3” (OMB Control Number 0910-0523). The revision is mandated by the Cures Act and pertains to FDA’s Office of Combination Products’ (OCP) designated combination product-specific submission
FDA Policy/General
Federal Register notice: FDA has sent to OMB an information collection extension entitled “Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities” (OMB Control Number 0910-0883). This is an extension of research that began last year. FDA says it has learned about barriers and opportunities encountered
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: AuroLife Pharma, Dayton, NJ (10/16): FDA inspected the firm 1/13-2/12 and found significant GMP violations for finished pharmaceuticals.
FDA Policy/General
Three Covington & Burling attorneys say in an online post the incoming administration of President-elect Joe Biden is likely to have these priorities at FDA: * science-based decision-making to highlight career scientific staff and rebuild what is seen as an erosion of public trust in federal health agencies;
FDA Policy/General
FDA Office of Trade, Mutual Recognition, and International Arrangements senior advisors Anne Kirchner and Joseph Rieras say the United States-Mexico-Canada Agreement (USMCA) that took effect 7/1 “aligns regulatory standards with agency practices, betters the quality of products available to American consumers, and levels the playing field for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives. The document is intended to assist sponsors in evaluating the need for and design drug-drug interaction (DDI) studies involving combined oral contraceptives during drug development as well as determining how
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Elemental Impurities in Animal Drug Products — Questions and Answers.” The document provides recommendations to sponsors on the control of elemental impurities in animal drug products, including all dosage forms and routes of administration. To view the notice, click here.
FDA Policy/General
Guide on Drugs for Cytomegalovirus in Transplants Federal Register notice: FDA makes available a final guidance on developing drugs for cytomegalovirus in transplantation. 11/20/2020 Guide on Posterior Cervical Screw Classification Federal Register notice: FDA makes available a final guidance entitled “Classification of Posterior Cervical Screw Systems: Small Entity
FDA Policy/General
Federal Register notice: FDA is announcing the availability of a draft guidance for industry entitled Cross Labeling Oncology Drugs in Combination Drug Regimens. The document describes the agency’s current recommendations on including relevant information in labeling for oncology drugs approved for use in combination drug regimens, including important consideration
Drugs
Johnson & Johnson (J&J) subsidiary Medical Device Business Services has agreed to pay $10 million to settle allegations under the False Claims Act that former J&J subsidiary Therakos promoted Uvar XTS and Cellex extracorporeal photopheresis systems for unapproved uses in pediatric patients between 2006 and 2012.
FDA Policy/General
Federal Register notice: FDA has updated its ongoing listing of issued and reissued Emergency Use Authorizations (EUAs) for medical devices related to the Covid–19 public health emergency. The authorizations contain, among other things, conditions on the emergency use of the EUA products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA makes available 30 additional draft and revised draft product-specific guidances on the design of bioequivalence studies to support ANDAs. To view the notice, click here.