Health Care & Hospital Law
Jun. 16, 2020
Bill would bring drugs that treat serious conditions to market faster
Recently, Sen. Mike Braun introduced the Conditional Approval Act, which would amend the Federal Food, Drug and Cosmetic Act to allow for a shorter pathway to market -- that is, to allow for an early, provisional, and time-limited approval -- for drug candidates that meet six criteria.
Georgia C. Ravitz
Georgia was a partner in Wilson, Sonsini, Goodrich & Rosati PC's life sciences practice, where she specializes in FDA regulatory, health care, and consumer products innovation and compliance. Prior to joining the firm, Georgia was a senior partner in the FDA and advertising practices of Arent Fox in Washington, D.C., where she led the firm's consumer product safety practice.
David M. Hoffmeister
Partner
Wilson Sonsini Goodrich & Rosati PC
David plays a major leadership role in the firm's drug and device regulatory and health care law practice and brings more than 25 years of experience in drug and device regulatory and health care law. David was named as one of the "25 Leading Biotech Attorneys" in California in 2011 by the Daily Journal, and is recognized as one of the leading food and drug regulatory lawyers in the country.
James R. Ravitz
Partner
Jamie was a partner in Wilson Sonsini's life sciences practice, representing manufacturers and distributors of products regulated by the FDA, including medical devices, drugs, biologics, food, cannabis, dietary supplements, and cosmetic products. Before joining the firm, Jamie led the FDA and health care life sciences practice at Arent Fox in Washington.
Vern Norviel
Partner
Wilson Sonsini Goodrich & Rosati PC
Vern is a senior practitioner in the firm's Patents and Innovations Strategies practice.
Charles Andres
Senior counsel
Wilson Sonsini Goodrich & Rosati PC
Charles is senior counsel in the firm's Patents and Innovations Strategies practice and the firm's U.S. Food and Drug Administration, Healthcare, and Consumer Products Compliance practice.
Prashant Girinath
Associate
Wilson Sonsini Goodrich & Rosati PC
Recently, Sen. Mike Braun (R-Ind.), introduced the Conditional Approval Act (S.3133). The act would amend the Federal Food, Drug and Cosmetic Act (21 U.S.C. 351 et seq.) to allow for a shorter pathway to market -- that is, to allow for an early, provisional, and time-limited approval -- for drug candidates that meet six criteria.
In proposing the act, Braun noted: "Patients with fatal diseases are fighting for their lives every day while real, meaningful, life-extending treatments...
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