Drugs
FDA is providing additional information through a just-posted question-and-answer document about its new Quality Manufacturing Maturity (QMM) Prototype Assessment Protocol Evaluation Program, which is described as the next phase in CDER’s QMM program. A 1/25 Federal Register announcement said the agency was seeking nine drug
Drugs
FDA has released a final guidance entitled “Controlled Correspondence Related to Generic Drug Development.” The document provides information on how generic drug manufacturers can submit controlled correspondence requesting information related to generic drug development. It also describes the agency’s process for providing responses related to such correspondence. The document
FDA Policy/General
FDA has released a cross-Center paper entitled “Artificial Intelligence (AI) & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” The paper, which applies to drugs, devices, biologics, and combination products, says “end-to-end management of AI applications is an iterative process that starts from ideation
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” The document provides an overview of the mechanisms available for device sponsors to request interactions with FDA related to medical device submissions. It also provides clarification
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling.” The document describes relevant information that should be provided in premarket submissions to support the evaluation of thermal effects of medical devices that produce local,
FDA Policy/General
Federal Register notice: FDA is amending certain medical device regulations to update a citation for information collection and conform to the regulatory provisions to the Federal Food, Drug, and Cosmetics Act. The rule does not impose any new requirements on affected parties, and this notice is editorial in nature to
Devices
FDA has published a draft guidance, Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling, describing relevant information that should be provided in a premarket submission to support the evaluation of thermal effects of medical devices that produce local, regional, and/or systemic changes in
Devices
FDA has published an updated draft guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, giving an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. The document says the interactions can include written
Drugs
The API Innovation Center makes these recommendations on an FDA draft guidance on the advanced manufacturing technologies (AMT) designation program: * consider whether to limit AMT designations to the U.S. and whether to include an accelerated review component; * distinguish incentives between generic and branded manufacturers; * expand the definition of AMT
Drugs
FDA has granted Poseida Therapeutics an orphan drug designation for its P-BCMA-ALLO1, a BCMA-targeted allogeneic, T stem cell chimeric antigen receptor (CAR)-T therapy candidate for treating multiple myeloma. Poseida is currently evaluating P-BCMA-ALLO1 in a Phase 1 clinical trial and recently shared early safety
Devices
FDA has cleared an Ortho Development 510(k) for its Trivicta Hip System, a triple-taper femoral stem that is intended to facilitate an optimal fit within the hip’s canal for a diverse range of patient anatomies. The device is designed for initial and long-term stability, and it
Devices
Johnson & Johnson’s Medos International Sarl device unit has recalled (Class 1) its Cerebase DA Guide Sheath after receiving an increase in complaints about fractures at the distal end, which may result in surgical procedural delay, vascular injury, and rare embolism events. The company recently sent an urgent medical
FDA Policy/General
Federal Register notice: FDA is correcting a 12/18 notice that announced the withdrawal of two NDAs. That notice indicated that the agency was withdrawing NDA 022424, Flowtuss (guaifenesin 200 mg/5 mL and hydrocodone bitartrate 2.5 mg/5 mL) oral solution held by Chartwell RX Sciences. Chartwell has
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports.” The document updates the existing E2D guidance entitled “E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting,” published
Drugs
A Science report supported by the Science Fund for Investigative Reporting details FDA’s concerns about the results of tests conducted in a City University of New York (CUNY) laboratory run by pharmacologist Hoau-Yan Wang on Cassava Sciences’ potential Alzheimer’s drug simufilam. The article says (includes a link
Devices
Sen. Bill Cassidy (R-LA), who says FDA is exceeding its legislative authority in seeking to reform clinical test regulation through rulemaking, is asking stakeholders for their ideas on how Congress can modernize current regulations to support innovation and ensure the tests are safe and effective to use. In an
Drugs
FDA has approved a Madrigal Pharmaceuticals NDA for Rezdiffra (resmetirom) for treating adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis). “NASH is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver
Drugs
FDA has published an International Council for Harmonization (ICH) draft guidance, E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports, with guidance on definitions and standards for post-approval individual case safety reporting and good case management practices. The document says
Drugs
The FDA Oncology Drugs Advisory Committee (ODAC) will consider on 3/14 whether the benefits of Geron’s imetelstat (proposed trade name Rytelo) in treating some blood cancers outweigh its risks. The company is seeking an indication to treat transfusion-dependent anemia in adults with low-to intermediate-1 risk
Drugs
FDA is asking the Oncologic Drugs Advisory Committee to discuss on 3/15 an increased number of deaths in two cancer drugs whose manufacturers have submitted sBLAs for a new indication. The committee will consider the sBLA submitted by Celgene for its Abecma (idecabtagene vicleucel) to treat adults with relapsed
Devices
Attorney Benjamin Zegarelli (Mintz) says that until Congress gives FDA new authorities to regulate software as a medical device (SaMD), the agency must get creative to keep up with rapidly evolving technology. Writing in an online post, Zegarelli says that “with the rise of artificial intelligence (AI) and machine learning
FDA Policy/General
FDA associate commissioner for global policy and strategy Mark Abdoo says the Biden administration’s budget proposal for the next fiscal year requests $1 million in new funding to begin the process of expanding the agency’s foreign footprint. Speaking on 3/12 to the 25th Session of the International