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Food and Drug Administration (FDA) FDA Approval Legislative Agendas

Bradley Arant Boult Cummings LLP

FDA Chief Says CBD Is Not NBD, Urges Congressional Action

Supporters of hemp-derived cannabidiol (CBD) who hoped the Food and Drug Administration would adopt a more progressive view of CBD were disappointed when FDA Chief Robert Califf recently testified that FDA does not consider...more

Manatt, Phelps & Phillips, LLP

[Webinar] Navigating the Mainstreaming of Psychedelic Drugs in the United States - October 3rd, 1:00 pm - 2:00 pm ET

In recent years, an unprecedented level of interest in the promise of psychedelics has taken hold. In the United States, many types of psychedelics are being investigated for use in treating an array of mental health...more

Manatt, Phelps & Phillips, LLP

FDA Issues New Draft Guidance on Clinical Testing of Psychedelic Drugs

On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 4

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In Washington: President Trump left Walter Reed Medical Center Monday evening despite his personal doctor, Sean Conley, saying he “may not be entirely out of the woods yet.” In a memo on Tuesday, his doctor said the...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – August 2020 # 14

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In Washington - Senator Bill Cassidy (R-LA) has tested positive for coronavirus. Cassidy took a test on Thursday evening after being informed that he had been exposed to an individual with COVID-19. He is quarantining for...more

Seyfarth Shaw LLP

FDA and NCI to Review COVID-19 Antibody Tests Marketed Under FDA Guidance Permitting Sale Without FDA Authorization

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In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more

Hogan Lovells

Senate bill proposes laboratory developed tests to be regulated under CLIA process

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U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Continues to Approve Biosimilars

The prevailing attitude in many quarters is that the Biologics Price Competition and Innovation Act (BPCIA) has not facilitated approval of drugs biosimilar to reference biologic drug products with sufficient alacrity and has...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues

Letters and Statements - Gene Therapy: Democratic Senators Urge the FDA to Hold Company Accountable for Falsifying Data - On August 9, 2019, a group of Democratic senators, including two presidential candidates, sent...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018

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Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we...more

Hogan Lovells

A new right for American patients: The Right to Try

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On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the “Right to Try Act of 2017” by a vote of 250-169. The bill gives certain patients with life-threatening conditions the right to...more

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