Medical Regulation > Nova Content
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On September 23, 2022, the Food and Drug Administration (FDA) published a draft guidance aimed to protect children who participate in clinical...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 »
The FDA has published new web pages about Monkeypox and medical devices. The new web page, titled Monkeypox and Medical Devices, includes ... Read More »
Less than two months ago, Curevac filed a lawsuit in the German Regional Court in Düsseldorf against BioNTech over patent... Read More »
In early 1983, Bolar Pharmaceutical Inc. wanted to bring a generic version of the Dalmane drug, a sleeping pill, to the market. At that... Read More »
Small molecule drugs have been the norm for much of medicine’s history. Only in the past decade has there been a rise ... Read More »
Written by: Mark Rubinshtein, Ph.D.
SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the... Read More »
On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s... Read More »
On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices... Read More »