FDA Policy/General
Federal Register notice: FDA is seeking comments on the information collection requirements in its “Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act: OMB Control Number 0910–0777. A facility that compounds drugs may elect to register
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.” The correspondence process was identified as part of the performance goals and program enhancements for the Generic Drug User Fee Amendments reauthorization for Fiscal Years 2018–2022. The guidance describes
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. China Resources Zizhu Pharmaceutical Co., Ltd. Beijing, China (4/24): FDA inspected the firm and cited significant GMP deviations associated with its active pharmaceutical ingredients manufacturing. For example, the
FDA Policy/General
Federal Register notice: FDA has proposed a new drug advertising study entitled “Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads.” The study is intended to examine how repetition and over-warning apply to risk presentations in direct-to-consumer print advertising. The research aims
FDA Policy/General
Federal Register notice. FDA is seeking comments on an information collection extension for requirements for accepting “Electronic Records; Electronic Signatures — 21 CFR Part 11; OMB Control Number 0910–0303.” To view the notice, click here.
FDA Policy/General
Federal Register notice. FDA is seeking comments on an information collection extension for “Common European Medicines Agency (EMA)/FDA Application Form for Orphan Drug Medicinal Product Designation (Form FDA 3671).” To view the notice, click here.
FDA Policy/General
FDA Seeks Nominations for Radiation Standards Panel Federal Register notice: FDA requests nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. 06/16/2017 FDA Seeks Consumer Reps for Advisory Panels Federal Register notice: FDA requests nominations for voting and nonvoting consumer representatives to
FDA Policy/General
FDA’S Center for Veterinary Medicine (CVM) 6/16 called for applications for grants as high as $450,000 to support the development of new animal drugs intended for minor species or minor uses in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens). The Center’s announcement listed
FDA Policy/General
Federal Register notice: FDA is requesting nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. The panel provides advice and consultation on the technical feasibility, reasonableness, and practicability of performance standards for electronic products to control radiation emissions from such products. To view the
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting and nonvoting consumer representatives to serve on advisory committees and panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act—OMB Control Number 0910–0776.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Form FDA 3728, Animal Generic User Fee Act Cover Sheet — 21 U.S.C. 379j — OMB Control Number 0910–0632.” The cover sheet is designed to collect the minimum necessary information to determine whether a fee is
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection on “Data To Support Social and Behavioral Research as Used by the Food and Drug Administration — OMB Control Number 0910.” The agency says understanding patients, consumers, and health care professionals’ perceptions and behaviors plays an important role in
FDA Policy/General
Federal Register notice: FDA is seeking notice from industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee. The agency is also requesting nominations for a nonvoting industry representative to serve on the panel. A nominee may
FDA Policy/General
Federal Register notice: FDA is seeking comments on proposed research entitled “Disclosures in Professional and Consumer Prescription Drug Promotion.” The agency notes there is little or no published research on disclosures in prescription drug promotion, either directed to consumers or to healthcare providers. The proposed research will examine the effectiveness
FDA Policy/General
Federal Register notice: FDA has announced a 7/10-11 public workshop entitled “Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities.” The workshop is intended to discuss challenges in using
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Color Additive Certification Requests and Recordkeeping—21 CFR Part 80— OMB Control Number 0910–0216.” The notice involves FDA’s regulations governing batch certification of color additives manufactured for use in foods, drugs, cosmetics, or medical devices
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. A-S Medication Solutions Libertyville, IL (6/5): FDA recently reviewed the firm’s listing files and has identified many instances where the listing information failed to comply with
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection involving new research entitled “Utilization of Adequate Provision among Low to Non-Internet Users.” The primary purpose of the research is to examine the value of including both the 1-800 number and print ad as part of
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection reinstatement for “Electronic Products OMB Control Number 0910–0025.” The notice applies to requirements to establish and carry out an electronic product radiation control program, including the development, issuance, and administration of performance standards to control the emission of
FDA Policy/General
Federal Register notice: FDA has announced a 6/26 Science Board meeting. Panel members will be given an update on FDA’s biotechnology activities related to plant-derived food and animals, and will hear a report from the National Antibiotic Resistance Monitoring System Review Subcommittee. To view the notice, click
FDA Policy/General
DEVICES FDA has approved a Qiagen PMA supplement for QuantiFeron-TB Gold Plus, a fourth-generation blood test for detecting latent tuberculosis (TB) infection. The device adds the company’s proprietary CD8+ technology to “offer the ability to capture a much broader picture of an individual’s immune response to