💊Implications of New Nonprescription Drug Regulations for Businesses
In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule, entitled "Nonprescription Drug Product With an Additional Condition for Nonprescription Use," (ACNU) was delayed until March 21, 2025. Additional time is needed for review; therefore, the delay is extended for an additional 60 days.
Learn More💊Notice of Proposed Production Activity for Pfizer in FTZ 43
Pfizer, Inc. has submitted a notification for proposed production activity within Foreign-Trade Zone (FTZ) 43E in Kalamazoo, Michigan, involving the manufacturing of a pharmaceutical intermediate product. This notification outlines the specific foreign-status materials and production benefits available under FTZ procedures, inviting public comments regarding this proposal.
Learn More💊Fisher Clinical Services' Application for Controlled Substance Importation
Fisher Clinical Services, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊FDA Withdraws Approval of Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of four abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Learn More💊FDA Withdraws Approval for ZULRESSO (Brexanolone) Solution
The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for ZULRESSO (brexanolone) solution, 100 milligrams (mg)/20 milliliters (mL), held by Sage Therapeutics, Inc., 55 Cambridge Parkway, Cambridge, MA 02142 (Sage). Sage notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
Learn More💊Patheon Pharmaceuticals Applies for Controlled Substances Manufacturing Registration
Patheon Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More⚗️Sigma Aldrich Controlled Substances Application Overview
Sigma Aldrich Research Biochemicals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More💊Indivior Inc. Seeks Registration for Importing Controlled Substances
Indivior Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💰NIH Closed Meetings
The Department of Health and Human Services announces closed meetings by the National Institutes of Health to review grant applications for various scientific study sections. These meetings intend to focus on evaluating proposals that may involve confidential trade secrets and personal information. The meetings will be conducted virtually and are closed to the public.
Learn More🏭EPA NESHAP for Pharmaceuticals Production Renewal Notice
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Pharmaceuticals Production (EPA ICR Number 1781.10, OMB Control Number 2060-0358) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through February 28, 2025. Public comments were previously requested via the Federal Register on May 18, 2023 during a 60-day comment period. This notice allows for an additional 30 days for public comments.
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