Medical Regulation > Nova Content
Written by: Philip M. Nelson
Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve... Read More »
Written by: Joshua C. Loader
The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical ... Read More »
British drugmaker GlaxoSmithKline (GSK) has taken American pharmaceutical giant Pfizer to court, alleging a... Read More »
In the world of pharmaceuticals, access to affordable generic drugs is crucial for ensuring cost-effective... Read More »
Written by: Arash Pia
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory... Read More »
Written by: Zachary B. Messick
The FDA implemented the breakthrough device program in 2015. The program was designed to... Read More »
Written by: Michael R. Christensen
On August 22-23, 2023, the FDA will conduct an Advisory Committee... Read More »
Written by: Mark Rubinshtein, Ph.D.
Neuralink, the biotechnology company founded by Elon Musk, has received approval from the... Read More »
Written by: Julie Kim
On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™. GE... Read More »
Written by:Matthew Ruth & Philip M. Nelson
Going forward, medical device approval will require the device maker to provide... Read More »
In the world of pharmaceuticals, the Abbreviated New Drug Application (ANDA) process plays a critical role in the approval and market... Read More »
Written by: Raina Patel
The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled ... Read More »
Written by: Alistair J. McIntyre
The FDA recently announced release of final transition guidance documents for... Read More »
Written by: Paige L. Cappelli
The FDA recently announced that it is seeking a budget of $7.2 Billion for 2024, part of... Read More »
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Written by: Nima Zargari, Ph.D.
On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, the U.S. Court of... Read More »
Written by: Albert J. Sueiras
Cochlear implant developer Advanced Bionics LLC will pay about $12 million to resolve... Read More »
EndoStim announced on October 25th that the FDA granted a breakthrough device designation for the company’s implantable... Read More »
In late August, we published our third annual ANDA Litigation Intelligence Report, covering important statistics and evaluating all stakeholders in ... Read More »
On September 28, 2022 the FDA announced a collaboration with the Veterans Health Administration (VHA), in particular the VA Ventures ... Read More »
On September 23, 2022, the Food and Drug Administration (FDA) published a draft guidance aimed to protect children who participate in clinical... Read More »