FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff.” The document describes and explains a 2016 final rule on postmarketing safety reporting (PMSR) for combination products. It provides recommendations for complying with the PMSR requirements as
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. High Chemical Co., Waretown, NJ (7/2): FDA inspected the firm in February and found significant GMP deviations with active pharmaceutical ingredients (API). For example, the firm failed to
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection for “Generic Clearance for Quick Turnaround Testing of Communication Effectiveness.” The collection is intended to allow FDA to use quick turnaround surveys, focus groups, and in-depth interviews collected from consumers and other stakeholders to communicate FDA issues
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Experimental Study of an Accelerated Approval Disclosure * Interstate Shellfish Dealer’s Certificate * Administrative Detention and Banned Medical Devices * Medical Device User Fee Small Business Qualifications and Certifications * Individual Patient Expanded Access
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Bar Code Label Requirement for Human Drug and Biological Products” (OMB Control Number 0910-0537). The agency requires bar codes on most human prescription drug products and on over-the-counter drug products that are dispensed under
FDA Policy/General
FDA has released a final guidance on “Postmarketing Safety Reporting for Combination Products.” The document addresses how to comply with a 2016 final rule on postmarketing safety reporting (PMSR) requirements for combination products. “Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations
FDA Policy/General
Merck Darmstadt, Germany, Pfizer and Syndax Pharmaceuticals have entered into a collaboration agreement to evaluate avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Syndax’s entinostat, an investigational oral small molecule that targets immune regulatory cells in patients with heavily pre-treated, recurrent ovarian
FDA Policy/General
DEVICES FDA has approved an Advance Circulatory Systems PMA for the ResQCPR System, a two-device system for first responders to use while performing cardiopulmonary resuscitation (CPR) on people in cardiac arrest. The first device, the ResQPump Active Compression Decompression CPR Device, has a double-grip handle that when attached
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for its “Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria,” (OMB Control Number 0910-0510). The guidance provides information for those
FDA Policy/General
Federal Register notice: FDA has announced that it will adopt the current version of the Geopolitical Entities, Names, and Codes (GENC) Standard on 12/17/2020. The standard specifies an authoritative set of country codes and names for use by the U.S. Government for information exchange, using ISO 3166
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) is proposing to conduct research to determine how physician perceptions are influenced by drug marketing, specifically with variations in information context (presence of graphical elements and information delivery vehicle— medical journal abstract or sales aid), methodologic rigor of the underlying clinical study
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension on the “Guidance: Emergency Use Authorization of Medical Products and Related Authorities,” (OMB Control Number 0910-0595). The guidance describes the data to support issuance of an emergency use authorization. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues” that describes the agency’s current recommendations regarding the overall development program and clinical trial designs for such products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Center for Devices and Radiological Health Appeals Processes” (OMB Control Number 0910-0738). The guidance describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. To view the notice,
FDA Policy/General
The Western District of Arkansas federal court has ordered J and L Grocery (Alma, AR) to stop distributing drug products, medical devices, cosmetics and food until the company complies with FDA requirements listed in a consent decree. “According to the amended complaint, J and L Grocery held FDA-regulated products
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Medical Device User Fee Cover Sheet, Form FDA 3601” (OMB Control Number 0910-0511). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Guidance on Reagents for Detection of Specific Novel Influenza A Viruses — 21 CFR Part 866” (OMB Control Number 0910–0584). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has released a draft guidance entitled “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Revision 7).” The document outlines certain circumstances where FDA may determine that a short-term waiver from electronic common technical document submission
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications — 21 CFR Part 3” (OMB Control Number 0910-0523). The regulation specifies how FDA will determine the organizational component within the agency assigned to have primary
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Focus Groups About Drug Products as Used by the Food and Drug Administration” (OMB Control Number 0910-0677). The agency says focus groups are intended to provide a more in-depth understanding of individuals’ attitudes, beliefs, motivations,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0827). Outsourcing facilities must register with and submit regular reports identifying the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry on Hypertension Indication: Drug Labeling For Cardiovascular Outcome Claims” (OMB Control Number 0910-0670). The collection encourages the submission of supplemental labeling and is intended to assist applicants in developing labeling for outcome