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Life Sciences › Center for Drug Evaluation and Research (CDER) › Biologics

Ropes & Gray LLP

Anything Worth Doing Is Worth Doing Right: FDA Issues Draft Guidance on Requirements and Processes for Accelerated Approval

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On December 5, 2024, the U.S. Food and Drug Administration (“FDA”) issued a much anticipated draft guidance for industry on accelerated approval that provides additional clarity on FDA’s expectations for accelerated approval...more

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

JPM2024: What to expect from FDA in an election year

Hogan Lovells on

Despite continued perceived economic headwinds, cutting edge research continues to provide new opportunities for life saving therapies for patients. However, early development programs for advanced medicines using innovative...more

Hogan Lovells

Getting START’ed: New FDA programs aim to advance drugs to treat rare diseases

Hogan Lovells on

On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program called Support for clinical Trials Advancing Rare...more

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

BakerHostetler

Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

BakerHostetler on

On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

American Conference Institute (ACI) on

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Locke Lord LLP

FDA Issues Guidance Detailing Current Policies on Facility Inspections and Product Approvals During the COVID-19 Pandemic

Locke Lord LLP on

The COVID-19 pandemic presents ongoing challenges to the pharmaceutical and biologics industries, where in-person inspection of facilities is often required for FDA approval of applications to market drug or biological...more

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