News & Analysis as of

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

Hogan Lovells

FDA promotes user fee waiver options for combination products

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The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance...more

Goodwin

FDA Launches Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program

Goodwin on

On May 31, 2024, the FDA announced initiation of the Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program. The START program, led by the Center for Biologics Evaluation and Research (“CBER”)...more

Troutman Pepper

New FDA Guidance on AI and Medical Products

Troutman Pepper on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Epstein Becker & Green

Unpacking Averages: Analyzing FDA’s Performance in Finalizing Guidance Documents

FDA’s January 3, 2024, Federal Register notice soliciting comments on the agency’s plan to implement best practices for guidance development got me thinking.  What do the data show regarding FDA’s performance in moving...more

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

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

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

MoFo Life Sciences

FDA Publishes Digital Health Technology Framework

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On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center...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

American Conference Institute (ACI)

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

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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