News & Analysis as of

Pharmaceutical Industry Food and Drug Administration (FDA) Small Business

Skadden, Arps, Slate, Meagher & Flom LLP

CARES Act Provides Much-Needed Stimulus for U.S. Businesses, Individuals

On March 27, 2020, Congress approved the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to provide financial assistance to individuals and businesses, which in aggregate greatly exceeds the financial package...more

Arnall Golden Gregory LLP

Money for Nothin': FDA's PDUFA Fee Waivers and Exemptions

Lately, we have received a number of client inquiries about prescription user fee waivers. The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes FDA to collect fees from companies that produce certain human...more

McDermott Will & Emery

21st Century Cures: A Closer Look

McDermott Will & Emery on

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

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