Medical Regulation > Nova Content
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On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s...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 »
Global health care spending is predicted to reach $10 trillion USD during 2022 with almost 30% of it belonging to the USA. It might sound... Read More »
Medtronic recently announced that it received clearance from the FDA and CE Mark approval for its LINQ II insertable cardiac monitor (ICM). The announcement notes... Read More »
The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special”... Read More »
Last year, in a lengthy split decision, a Fed. Cir. panel affirmed the district court’s ruling that four “add-on” patents that Acorda owned were... Read More »
On March 7, 2019, the U.S. Food and Drug Administration (FDA) and the U.S. Food Safety and Inspection Service (FSIS) announced a formal agreement, in the form of a... Read More »
Abbott announced on October 19, 2018 that its HeartMate 3 Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as... Read More »
The U.S. Food and Drug Administration recently announced approval for Bose to market their Bose Hearing Aid. According to the press release, the Bose... Read More »
The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership... Read More »
The Food and Drug Administration (FDA) recently unveiled the Quality in 510(k) (“Quik”) Review pilot program, aimed at reducing the time it takes to... Read More »
Since its first release in 2015, the Apple Watch has continued to evolve and incorporate more health- and fitness-tracking capabilities. The latest version of... Read More »
The FDA recently announced its approval of GW Pharmaceutical’s Epidiolex drug, described as the first ever plant-derived cannabinoid medicine in the United... Read More »
On September 12, 2018, Apple released its new Apple Watch Series 4 with a new ECG app that can take an electrocardiogram (ECG). Apple’s new Apple Watch Series 4 ... Read More »
The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the... Read More »