FDA Policy/General
Federal Register notice: FDA has announced a 5/30-31 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. On 5/30, panel members will discuss and make recommendations on a reclassification proposal for surgical stapler devices for internal use from Class 1 (general controls) to
FDA Policy/General
Federal Register notice: FDA has made available an update to the immediately in effect guidance entitled “Compliance Policy for Combination Product Postmarketing Safety Reporting.” The document describes FDA’s compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety
FDA Policy/General
In a case that could have implications for FDA and many other federal agencies, the Supreme Court is being asked by the Food Marketing Institute to broaden one of the exemptions under the Freedom of Information Act (FOIA) so the government can refuse to disclose SNAP (formerly Food Stamp) program
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify surgical staplers for internal use (currently regulated under the classification for “manual surgical instrument for general use” and assigned the product code GAG) from Class 1 (general controls) into Class 2 (special controls) and subject to premarket review. The reclassification is related
FDA Policy/General
FDA has issued a draft guidance, Initiation of Voluntary Recalls Under 21 CFR part 7, Subpart C, on the timely initiation of voluntary recalls of FDA-regulated products. The document discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures;
FDA Policy/General
Researchers with CDER’s Office of Prescription Drug Promotion and RTI International say new research into effects of direct-to-consumer drug advertising and promotion is needed given the changing environment in which such ads are used. Writing in Health Communication, the researchers say their review synthesized the research literature
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: Abaxis, Union City, CA (4/12): FDA inspected the firm 4/9-25 and cited changes the company made to its Piccolo
FDA Policy/General
Federal Register notice: FDA has announced a 5/16 public meeting entitled “Characterizing FDA’s Approach to Benefit-Risk Assessment Throughout the Medical Product Life Cycle.” The meeting is intended to gather stakeholder input on applying FDA’s Benefit-Risk Framework throughout the human drug lifecycle and best approaches to
FDA Policy/General
Federal Register notice: FDA has announced a 6/6 Antimicrobial Drugs Advisory Committee meeting to discuss a Global Alliance for TB Drug Development NDA for pretomanid tablets for oral administration. The submission seeks a proposed indication as part of a combination regimen with bedaquiline and linezolid in adults for treating
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Deeming Tobacco Products To Be Subject to the FD&C Act” (OMB Control Number 0910-0768). The collection is related to premarket tobacco applications that require full reports of all investigations of health risks; a full
FDA Policy/General
Federal Register notice: FDA has announced a 6/19 meeting of its Circulatory System Devices Panel of the Medical Devices Advisory Committee. Panel members are scheduled to discuss and make recommendations on information related to recent observations of increased long-term mortality in peripheral arterial disease patients treated with paclitaxel-
FDA Policy/General
Assessment of Quantitative Imaging Devices Guide Federal Register notice: FDA makes available a draft guidance entitled “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.” 04/19/2019 Draft Guide on Nitinol-Containing Medical Devices Federal Register notice: FDA announces the availability of a draft guidance entitled “Technical Considerations
FDA Policy/General
DEVICES FDA has cleared a Bausch & Lomb 510(k) for its frequent replacement silicone hydrogel contact lenses made with MoistureSeal Technology. Medtronic has received FDA PMA approval for its MiniMed 530G with Enlite, an artificial pancreas system with Threshold Suspend automation for people with diabetes 16 and older. The
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.” The document says that manufacturers preparing premarket submissions for devices that include quantitative imaging functions should provide performance specifications for the quantitative imaging functions, supporting performance data to demonstrate
FDA Policy/General
Federal Register notice: FDA has announced the availability of a draft guidance entitled “Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol.” The document is intended to provide clarity and consistency in recommended non-clinical assessments across a variety of medical devices that contain nitinol. To view the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Bispecific Antibody Development Programs.” The document covers general considerations and recommendations for these programs, as well as regulatory, quality, nonclinical, and clinical considerations in the context of bispecific antibody development programs. It does not discuss development considerations for other
FDA Policy/General
Federal Register notice: FDA has extended the comment period for a 2/26 proposed rule on the regulation of over-the-counter sunscreen monograph products. Comments can now be submitted until 6/27. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has corrected a 2/26 proposed rule on the regulation of over-the-counter sunscreen monograph products. The document was published with formulas that were illegible, and corrections were made to improve its accuracy. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Abbreviated New Animal Drug Applications — Sections 512(b)(2) and (n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and (n)(1))” (OMB Control Number 0910-0669). To view
FDA Policy/General
Federal Register notice: FDA has determined that Cephalon’s Trisenox (arsenic trioxide) injection, 1mg/mL, was not withdrawn for 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. Trisenox is indicated in
FDA Policy/General
FDA has launched a new tool to alert the public when it becomes aware of ingredients that appear to be unlawfully marketed in dietary supplements — the online Dietary Supplement Ingredient Advisory List. The listing is intended to tell industry to avoid making or selling dietary supplements containing ingredients on the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for its “Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926” (OMB Control Number 0910-0814). To view the notice, click here.