FDA Policy/General
Federal Register notice: FDA has issued a proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. The proposed rule describes the conditions under which OTC sunscreen monograph products would be generally recognized as safe and effective and not misbranded. It is
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations.” The document revises and replaces part of a 2002 FDA guidance on “Food- Effect Bioavailability and Fed Bioequivalence Studies.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations.” The document revises and replaces an FDA 3/2014 draft guidance on “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations.’’ To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for an 11/20/2018 notice entitled “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments.” Electronic or written comments should be submitted by 4/29. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Pure Source Doral, FL (2/20): FDA inspected the firm 2/2018 and cited significant GMP violations for finished pharmaceuticals. For example, Pure Source failed to thoroughly investigate an
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances on, among other things, the design of bioequivalence studies to support ANDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Implanted Brain-Computer Interface Devices for Patients with Paralysis or Amputation — Nonclinical Testing and Clinical Considerations.” The document defines implanted brain-computer interface devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for an 11/15/2018 proposed rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” Electronic or written comments should be submitted by 3/7. To view the notice, click here.
FDA Policy/General
Draft Guide on Nicotine Replacement Drug Products Federal Register notice: FDA makes available a draft guidance entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products.” 02/22/2019 Rule on Bulk Drug Substances for Compounding Federal Register notice: FDA issues a final rule to establish criteria for
FDA Policy/General
BIOLOGICS FDA has approved a Protein Sciences BLA for its quadrivalent formulation of Flublok influenza vaccine, which protects against four strains of influenza, three of the same strains found in trivalent Flublok plus an additional B strain. Approval was based on data from a clinical study of 9,000 adults
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products.” The document reflects the agency’s current recommendations on overall development programs to support nicotine replacement drug products for smoking cessation and related chronic indications. It focuses on
FDA Policy/General
Federal Register notice: FDA has classified auto titration devices for oral appliances into Class 2 (special controls). This action follows a Zephyr Sleep Technologies request for de novo classification of the MATRx plus, which the agency identified as a prescription home use device that determines a target position to be
FDA Policy/General
Federal Register notice: FDA has issued a final rule to establish criteria for and identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the Food, Drug, and Cosmetic Act. The agency is placing six bulk drug
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments.” The document describes FDA’s proposed approach for providing nonbinding feedback, including the procedures for requesting it and FDA’s review of such requests. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.” The document describes the expedited programs available to sponsors developing regenerative medicine therapy for serious or life-threatening diseases or conditions. It also describes considerations in the clinical development of
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies (RMAT)” that provides the agency’s current thinking about how it intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products. It
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Mark Berman, Beverly Hills, CA (2/13): FDA inspected the physician’s operations 7/2018 and concluded he has been manufacturing a medical device known as the Pocket Protector,
FDA Policy/General
Comments Reopened on Real World Evidence Program Federal Register notice: FDA reopens the comment period on a 12/7/2018 notice entitled “Framework for a Real-World Evidence Program; Availability.” 02/15/2019 Panel to Discuss Breast Implant Benefit/Risk Federal Register notice: FDA announces a 3/25-26 General
FDA Policy/General
DEVICES FDA has expanded approval for an Abiomed PMA for the Impella CP heart pump and its use in high-risk percutaneous coronary interventions (PCI). In 2016, the agecny approved Impella CP for up to four days of use to treat patients suffering from cardiogenic shock. The expanded approval allows
FDA Policy/General
Federal Register notice: FDA is reopening the comment period on a 12/7/2018 notice entitled “Framework for a Real-World Evidence Program; Availability.” The agency is taking this action to allow interested people additional time to submit comments. Electronic or written comments on the document are now due by
FDA Policy/General
Federal Register notice: FDA has announced a 3/25-26 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. Panel members are scheduled to discuss benefits and risks of breast implants indicated for breast augmentation and reconstruction concerning the following topics: (1) Breast implant associated anaplastic
FDA Policy/General
Federal Register notice: CDER is providing an opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program. The program aims to propose explicit established conditions (ECs) as part drug submissions. The Center is implementing the program to gain experience receiving, assessing, and engaging with applicants