PDUFA VI: Fiscal Years 2018 – 2022

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/19/2025
Short Title (70 char) F.H. Investments Inc dba Asteria Health. Birmingham, AL. 483 issued 12/19/2025
FEI Number 3038253438
Firm Name F.H. Investments Inc dba Asteria Health
Record Type 483
State AL
Es

2025 Meeting Materials, Psychopharmacologic Drugs Advisory Committee

The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and

Compounders sometimes produce drugs using bulk drug substances or active pharmaceutical ingredients. Because compounding from these substances presents risks to patients, sections 503A and 503B of the FD&C Act place limits on the bulk drug substances that can be used in compounding.

Offers an innovative approach to facilitate the conduct of large-scale efficacy and safety trials through the purposeful reduction in the collection of certain types of data for drugs or biologics with a well-characterized safety profile.

Generic Drugs Offices and Divisions