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The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical ...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 »
Comments
Allen EhrlichAs an expert in medical devices, the FDA needs additional funding to speed up the timeline for approval of new innovative products. Hoping that Congress will approve this budget.
Mar 21, 2023
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 »