News & Analysis as of

Draft Guidance › Abbreviated New Drug Application (ANDA) › Drug Pricing

Latham & Watkins LLP

FDA Color Additive Scrutiny Expands to Pharmaceuticals

Latham & Watkins LLP on

FDA issued a draft guidance that lays the groundwork for drug companies to comply with changes to approved color additives....more

Wilson Sonsini Goodrich & Rosati

FDA Issues Competitive Generic Therapies (CGTs) Statement and Guidance Regarding CGT Designation, Approval Pathway, and Market...

Wilson Sonsini Goodrich & Rosati on

Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are...more

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