Publications

Hogan Lovells Publications

FDA doubles down on MUsT studies for sunscreens and issues final guidance on absorption studies that will likely be needed for continued marketing Focus On Regulation

On 10 May 2019 the U.S. Food and Drug Administration (FDA) published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied...

Hogan Lovells Publications

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans Focus on Regulation

On 23 April, Food and Drug Administration (FDA) issued draft guidance entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C," which aims to clarify how firms in a...

Hogan Lovells Publications

With the statutory deadline approaching, FDA issues a proposed sunscreens rule Focus On Regulation

On 26 February, the U.S. Food and Drug Administration (FDA) published the proposed rule, "Sunscreen Drug Products for Over-the-Counter Human Use," which describes the conditions under which ...

Media Mention

Sources: CBO Score Of OTC Monograph Could Be Sign Of Movement Inside Health Policy

David Horowitz discussed the Congressional Budget Office's (CBO) score of the U.S. Senate's over-the-counter monograph reform bill in the Inside Health Policy article titled "Sources: CBO...

Hogan Lovells Publications

Outlook for OTC drug regulation Hogan Lovells

Significant change is on the horizon for the over-the-counter (OTC) drug industry. OTC drug sales have grown from about US$3 billion in 1972 to over US$34 billion today, with over 300,000...

Hogan Lovells Publications

Life sciences and health care horizons

Hogan Lovells Publications

New legislation increases access to medical products for military applications

Today, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use...

Publications

FDA seizes stem cell therapy — A first of many? Hogan Lovells

On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for...

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