Medical Regulation > Nova Content
Written by: Jason J. Jardine
On October 27th, 2023, the U.S. Food and Drug Administration (FDA) approved LOQTORZITM... Read More »
Written by: Lucas P. Koziol, Ph.D. & Michael L. Fuller
On November 21, 2023, the FDA published its final rule... Read More »
Written by: Mengmeng Du
Neurovalens successfully secured 510(k) clearance from the FDA on October 27, 2023 for its Modius... Read More »
Written by: Raina Patel
The FDA issued a warning letter to Abiomed, for failing to seek approval for... Read More »
Written by: Alistair J. McIntyre
The looming government shutdown will likely slow the pace of work at the FDA. The federal government... Read More »
Written by: Alistair J. McIntyre & Jason J. Jardine
On September 26, 2023, Nexus Pharmaceuticals, LLC[1] announced[2] that it had... Read More »
Written by: Paige L. Cappelli
On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft... Read More »
Written by: Ari Feinstein & Jane Dai, Ph.D.
On June 2, 2023, drug manufacturer Shire US Inc. and related entity Shire LLC... Read More »
Written by: Nima Zargari, Ph.D.
On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on... Read More »
We are proud to announce that tomorrow marks the release of the fourth edition of our ANDA Litigation Intelligence Report. This year's report... Read More »
Written by: Kenneth O. Aruda, Ph.D.
Software is increasingly used as a medical device, transforming the healthcare industry with the... Read More »
In the realm of pharmaceuticals, the approval process for generic and brand-name drugs holds significant importance. The Hatch-Waxman Act, ... Read More »
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The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical ...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 »