FDA Policy/General
Federal Register notices: FDA has published eight notices about the regulatory review period determinations for the following drug products: * KemPharm’s Azstarys (serdexmethylphenidate and dexmethylphenidate), indicated for treating attention deficit hyperactivity disorder in patients six years of age and older. The regulatory review period is 1,676 days, of which
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Cara Therapeutics’ Korsuva (difelikefalin acetate), indicated for treating moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The regulatory review period is 4,625 days, of which 4,381 days occurred
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for G1 Therapeutics’ Cosela (trilaciclib), indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topetecan-containing regimen for extensive-stage small cell lung
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Shortages Data Collections.” The collection supports agency regulations giving CDRH authority to acquire and maintain detailed data on domestic inventory, manufacturing capabilities, distribution plans, and raw material constraints for medical devices that would be in high demand
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled Good Laboratory Practice (GLP) Requirements for Nonclinical Laboratory Studies — 21 CFR Part 58. The collection supports agency regulations that specify minimum standards for the proper conduct of safety testing. They also address facilities, personnel, equipment, standard operating
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Covid-19: Developing Drugs and Biological Products for Treatment or Prevention.” The document describes FDA’s current recommendations for Phase 2 and Phase 3 trials with a focus on trial population, trial design, efficacy endpoints, safety considerations, and statistical
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a 10/24 notice on the revised draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” Comments can now be submitted until 1/5/2024.
FDA Policy/General
Federal Register notice: FDA has determined that Indivior’s Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Buprenex
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Translation of GLP Study Reports: Questions and Answers.” The document provides information to sponsors and nonclinical laboratories about study reports being translated from the original language into English, and appropriate documentation to ensure accurate and complete study data are
FDA Policy/General
FDA is declining to take the action sought in an 8/3/2020 petition from Knowledge Ecology International to ban all music during the presentation of risk information in direct-to-consumer ads. In its response, the agency says its current approach includes the assessment of background music in ads,
FDA Policy/General
Federal Register notice: FDA is announcing a public workshop entitled “Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice.” The workshop will discuss aspects of complex adaptive, Bayesian, and other novel clinical trial designs. It may also serve as the basis of a future a
FDA Policy/General
Federal Register notice: FDA is announcing a 1/23/24/2024 public meeting entitled “Advancing Drug Development for the Prevention of Spontaneous Preterm Birth.” The meeting is intended to gather stakeholder input on the impact of preterm birth on families and on society, as well as on the ethical, regulatory,
FDA Policy/General
Federal Register final rule: FDA is issuing a final rule on direct-to-consumer television and radio advertisements for prescription drugs and a requirement that the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner. The rule establishes standards to determine
FDA Policy/General
FDA commissioner Robert Califf says some postmarketing evidence-generating studies are so important that they may need public funding to ensure they get completed. Speaking in a Yahoo! Finance video interview, Califf says he prefers to consider postmarketing evidence-generation as a way of looking forward rather than looking back.
FDA Policy/General
Federal Register notice: FDA is announcing a 12/14 public meeting entitled “Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement.” The workshop is intended to focus on how best to understand patients’ experiences living with a rare disease and how to incorporate those experiences, as well as
FDA Policy/General
Federal Register notice: FDA is requesting information to better understand the status of trading partners’ (manufacturers, wholesale distributors, dispensers, and repackagers) interoperable systems and processes for enhanced drug distribution security. The agency says that trading partners should be using the current stabilization period to continue to build and validate secure,
FDA Policy/General
A new FDA final rule sets five standards that the agency says drug marketers must follow to ensure their direct-to-consumer advertisement’s “major statement” is presented in a clear, conspicuous, and neutral manner. The rule, Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a
FDA Policy/General
Federal Register notice: FDA is making savailable a final guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act” and a draft guidance entitled “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications.
FDA Policy/General
Federal Register notice: FDA is announcing a 2/6/2024 meeting of the Medical Devices Advisory Committee’s General Hospital and Personal Use Devices Panel. It is scheduled to discuss and make recommendations on medical device supply chain resiliency and shortage issues, including the agency’s “506J Device List.” Manufacturers
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Assessing the Credibility of Computational Modeling and Simulation (CM&S) in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff.” The document provides a risk-informed framework for credibility assessment of CM&S used
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 7/8/2022 Federal Register announcing an agency determination of the regulatory review period for Genentech’s Rozlytrek tablets (entrectinib), indicated for treating certain adult patients with metastatic non-small cell lung cancer, among other indications. The earlier
FDA Policy/General
Federal Register notice: FDA is announcing a 2/2/2024 Medical Devices Advisory Committee’s Anesthesiology and Respiratory Therapy Devices Panel meeting. Panel members are scheduled to discuss ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentation. They will also discuss an approach to