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Center for Biologics Evaluation and Research (CBER) Labeling Food and Drug Administration (FDA)

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

Hogan Lovells

U.S. FDA: labeling guidance for sponsors incorporating prescription drug use-related software

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which describes how FDA intends to apply its drug labeling...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

American Conference Institute (ACI)

[Webinar] 40th FDA Boot Camp - March 22nd - 23rd, 8:15 am - 1:30 pm EST

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing the working knowledge of core essentials of FDA law and regulation, including the new amendments...more

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