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Pharmaceutical Industry › Food and Drug Administration (FDA) › Policy Statement

Foley Hoag LLP

Want to Say It Ain't So? FDA Guides Firms on How to Respond to Misinformation

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Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more

Morrison & Foerster LLP

FTC Alleges Improper Orange Book Listing of Drug Delivery Device Patents

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In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more

Troutman Pepper

FTC Issues Policy Statement Confirming Its Position That Improperly Listing Patents in the Orange Book May Be Considered a...

Troutman Pepper on

The Federal Trade Commission (FTC) has released a new Policy Statement addressing one of its long-standing concerns in the pharmaceutical industry: the improper listing of patents in the Orange Book. In an open meeting of the...more

Foley Hoag LLP

Recent Biden Administration Actions on Access to Medication Abortion

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In the first week of 2023, the Biden administration announced two actions centered on expanding access to medication abortion. The first involves a policy change by the FDA regarding the ability of retail pharmacies to...more

Hogan Lovells

FDA postpones foreign inspections amid growing concerns over coronavirus (COVID-19)

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On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020.  This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more

Hogan Lovells

Parsing products: FDA regulatory policy for multi-function medical devices

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On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more

Goodwin

White House Releases Policy Statement Calling For Elimination Of Federal Funding For FDA’s Pre-Market Review Costs

Goodwin on

The White House released a statement of administration policy on July 12 in response to the House of Representatives passing H.R. 2430, a bill that would reauthorize the FDA’s user fee programs, including FDA’s biosimilar...more

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