The OCE PFDD program fosters collaboration between FDA centers and external stakeholders involved in patient outcomes research in cancer populations.
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Hard Steel contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Hard Steel, a product promoted and sold for sexual enhancement on various websites, including www.hardsteelusa.com and possibly in some retail stores.Drug Shortages
Drug Shortages HomepageBulk Drug Substances Used in Compounding
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.Patient Engagement Collaborative
The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Public Engagement Staff.Monoclonal Antibodies: Streamlined Nonclinical Safety Studies
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies.”Hikma Injectables USA Inc. Dayton, NJ. 483 issued 08/08/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) Hikma Injectables USA Inc. Dayton, NJ. 483 issued 08/08/2025
FEI Number 3022897129
Firm Name Hikma Injectables USA Inc.
Record Type 483
State NJ
Establishment Type Outsourcing Fa
