FDA submitted a proposed information collection to OMB for Paperwork Reduction Act review regarding formal hearing administrative procedures and practices.
FDA withdraws approval of 34 new drug applications across multiple applicants whose manufacturers requested withdrawal due to discontinued marketing.
FDA determines that vasopressin 0.9% injection was not withdrawn for safety or effectiveness reasons, allowing approval of generic abbreviated new drug applications if other regulatory requirements are met.
FDA seeks 60 days of public comment on information collection requirements for Biologics License Applications under the Paperwork Reduction Act; deadline for comments is 60 days from Federal Register publication.
NIH requests 60-day public comment on proposed data collection for citizen science and crowdsourcing projects under Paperwork Reduction Act review; deadline is 60 days from publication.
Center for Scientific Review holds closed peer-review meetings to evaluate competitive grant applications across federal research programs and funding agencies.
FDA corrects contact information for the Expedited Investigational New Drug Pilot Program docket, which solicits public input on shortening timelines from drug identification to first-in-human clinical trials.
The FDA seeks OMB clearance for information collection procedures related to premarket approval of medical devices under the Paperwork Reduction Act.
Mars Petcare US voluntarily recalls two lots of PEDIGREE Can High Protein Chopped Chicken & Duck Flavor 13.2oz dog food due to potential fraudulent distribution and foreign material contamination.
Gellert Global Group recalls 8.1 oz packages of Aldi Brand Fusia Asian Inspirations Kimchi & Tofu Kimbap due to undeclared tuna that poses serious allergic reaction risk to consumers with fish allergies.
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