News & Analysis as of

FDA Approval Life Sciences Trump Administration

Pullman & Comley - Connecticut Health Law

A Progress Report on Psychedelic Drug Legislation in Connecticut and Nearby States

The burgeoning field of psychedelic medicine, which suffered a major setback last year when the Food and Drug Administration (FDA) rejected an application to approve the use of midomafetamine (MDMA) to treat post-traumatic...more

Morgan Lewis

UPDATE: Trump Administration’s Midnight Rulemaking to Exempt Certain Class I and II Devices from 510(k) Requirement Rescinded

Morgan Lewis on

In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, December 2020 # 5

Hogan Lovells on

In Washington: President-elect Joe Biden picked California Attorney General Xavier Becerra to be his health secretary. Becerra was a defender of the Affordable Care Act. Separately, Biden picked a Harvard infectious...more

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

Hogan Lovells on

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Hogan Lovells

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

Hogan Lovells on

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more

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