FDA Policy/General
30 No-Longer-Marketed NDAs Withdrawn
Federal Register notice: FDA is withdrawing approval of 30 NDAs from multiple applicants after they notified the agency that the products are no longer marketed. To view the notice, click here.
FDA Policy/General
FDA Policy/General
Comments Sought on ANDA Submissions Guide
Federal Register notice: FDA has established a docket to solicit comments on the content of Appendix A in the 7/2018 guidance for industry entitled “ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA.” The opportunity for comments fulfills an agency commitment under the generic drug user fee agreement.
FDA Policy/General
Info Collection on Device Sterilization Agreements
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150” (OMB Control Number 0910–0131). The collection supports the agency’s control mechanism that allows firms to manufacture and label medical devices as sterile at one
FDA Policy/General
9 ICH Vet Med Guidances Published
Federal Register notice: FDA is publishing the following nine guidances released by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products: (1) Draft guidance for industry entitled “Effectiveness of Anthelmintics: Specific Recommendations for Canines (Revision 1).” To view this notice, click here. (2) Draft guidance
FDA Policy/General
Info Collection on Mammography Quality Standards
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Mammography Quality Standards Act Requirements —21 CFR part 900” (OMB Control Number 0910-0309). The collection pertains to requirements in the Mammography Quality Standards Act for a federal certification and inspection program for mammography facilities; standards for
FDA Policy/General
Info Collection on Environmental Impact Considerations
Federal Register notice: FDA has submitted to OMB an information collection revision entitled: “Environmental Impact Considerations” (OMB Control Number 0910-0322). The agency notes that all applications or petitions requesting FDA action require the submission of an environmental assessment or a claim of categorical exclusion. To view the notice, click
FDA Policy/General
Medical Device Accessories Information Collection
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Device Accessories” (OMB Control Number 0910-0823). The collection supports FDA recommendations in its guidance on “Medical Device Accessories — Describing Accessories and Classification Pathways.” The document explains what devices the agency generally considers an “accessory” and
FDA Policy/General
Info Collection on Patent Restoration Petitions
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions—21 CFR Part 60” (OMB Control Number 0910-0233). The petitions address the part of a patent term that may be consumed during FDA’s
FDA Policy/General
FDA Updates Device Recognized Standards Listing
Federal Register notice: FDA is making available a publication entitled “Modifications to the List of Recognized Standards, Recognition List Number: 058.” The document is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. To view the notice, click here.
FDA Policy/General
Califf Combats Misinformation with 'Rumor Control' Page
Combatting misinformation is a top priority for FDA and commissioner Robert Califf, and in addressing this the agency has launched a new Web page dedicated to stopping rumors from spreading. The “Rumor Control” page encourages the public to not believe rumors, not pass them along, and get information from trusted
FDA Policy/General
Allergenic Products Advisory Panel Renewed
Federal Register notice: FDA has renewed its Allergenic Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 7/9. To view the notice, click here.
FDA Policy/General
50 NDAs Not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA has determined that 50 listed drug products were not withdrawn for safety or effectiveness reasons. The determination means that the agency will continue to approve ANDAs that reference the products as long as they meet relevant legal and regulatory requirements. To view the notice, click here.
FDA Policy/General
Understanding Drug Risks and Benefits in Tweets
FDA and Fors Marsh Group researchers say they have examined the tradeoffs for consumer understanding of drug risks and benefits when drugs are promoted in character-space-limited (CSL) communications such as tweets. “CSL communications present a challenge for maintaining fair balance between risks and benefits in direct-to-consumer
FDA Policy/General
Info Collection on Device Q-Submissions
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Q-Submissions Program for Medical Devices” (OMB Control Number 0910-0756). The document supports the agency’s guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” The revision pertains to a form
FDA Policy/General
Panel to Discuss Rebiotix BLA
Federal Register notice: FDA has announced a 9/22 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss a BLA from Rebiotix for Rebyota (fecal microbiota, live) for reducing the recurrence of Clostridioides difficile infection in adults following antibiotic treatment. To view the notice, click
FDA Policy/General
Delayed User Fee Reauthorization Will Hurt Recruitment: Woodcock
Principal deputy commissioner Janet Woodcock says that the Congressional stalemate over advancing the user fee reauthorization package will likely damage ongoing recruitment efforts to bring onboard over 600 new staff for the next five-year user fee period. Asked about this during an Alliance for a Stronger FDA 8/4
FDA Policy/General
FDA Seeks Comments on Scheduling Changes for 10 Drugs
Federal Register notice: FDA is seeking comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 10 drug substances. The comments will be considered in preparing a response from the U.S. to the World Health Organization regarding the abuse
FDA Policy/General
Woodcock Outlines IT Transformation at FDA
After decades of high-level neglect, FDA is at last modernizing its multiple, decentralized information technology (IT) systems. Principal deputy commissioner Janet Woodcock 8/4 told an Alliance for a Stronger FDA Webcast that the agency is now working toward transformational new efficiencies through an FDA-wide enterprise approach to
FDA Policy/General
FDA Releases More ANDA Draft Bioequivalence Guides
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances. The documents provide product-specific recommendations on the design of bioequivalence studies to support ANDA, among other recommendations. To view the notice, click here.
FDA Policy/General
E-submission Guide for Expedited Safety Reports
Federal Register notice: FDA has made available a draft guidance entitled “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.” The document provides instructions for the electronic submission of expedited individual case safety reports from IND-exempt bioavailability/bioequivalence studies through the FDA Adverse Event Reporting System
FDA Policy/General
Looking at the FDA/Industry ‘Revolving Door’
At least 2,700 ex-FDAers now work in the drug industry, while another 1,100 have come into the agency from industry. That’s the analysis developed by Grid based on information available from the Linkedin social media app. Grid says it looked into the FDA/industry revolving door
FDA Policy/General
Panel To Review Amylyx ALS Drug
Federal Register notice: FDA has announced a 9/7 Peripheral and Central Nervous System Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Amylyx Pharmaceuticals NDA for AMX0035 (sodium phenylbutyrate/taurursodiol) and its use in treating amyotrophic lateral sclerosis. To view the notice, click here.