Some Worry Reduction in Pharmaceutical Revenues May Impact New Drug R&D and Innovation -
Lowering prescription drug pricing has been a hotly debated issue well before 2022 and is expected to continue in 2022. In November...more
In September 2021, the Office of Scientific Investigations of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) issued a Warning Letter to dietary supplement company RAAS Nutritionals,...more
Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an article on managing IP development and capture at growing medtech start-ups that offers insight from executives at...more
Also Codifies FDA's Longstanding "Active Moiety" Approach for New Chemical Entity Exclusivity -
In April 2021, President Biden signed two bipartisan bills that aim to promote drug competition and to reduce prescription...more
On November 20, 2020, the Department of Health and Human Services (HHS) announced it was terminating the U.S. Food and Drug Administration's (FDA) Unapproved Drugs Initiative (UDI), which is further described in...more
The U.S. Food and Drug Administration (FDA) issued a guidance in June 2020 that sets forth recommendations for manufacturers of drug and biological products to ensure compliance with current good manufacturing practice (cGMP)...more
Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices -
Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG -
The wearable device market is emerging as a key player...more
6/19/2019
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The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more