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Results: 1-10 of 11,786

FDA Seeks Comments on Potential Marijuana Reclassification Under International Drug Control Treaty

Jackson Lewis PC
USA
April 19 2018

The Food and Drug Administration requested comments in a notice published in the Federal Register on April 9, 2018 concerning the “abuse potential

FDA inspection proposal provides valuable insight into scope of investigations

Keller and Heckman LLP
USA
April 18 2018

At yesterday’s meeting with the U.S. House Subcommittee on Agriculture and Rural Development to discuss FDA’s Fiscal Year 2019 budget, Food and Drug

FDA Guidance on Using Public Human Genetic Variant Databases for Genetic and Genomic-Based In Vitro Diagnostics

Finnegan, Henderson, Farabow, Garrett & Dunner LLP
USA
April 18 2018

On April 13, 2018, FDA issued final guidance on the Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and

Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry

Mintz Levin Cohn Ferris Glovsky and Popeo PC
USA
April 18 2018

In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include

USP Will Not Revise Its Biologics Monograph Without Stakeholder Consensus

Finnegan, Henderson, Farabow, Garrett & Dunner LLP
USA
April 18 2018

On April 2, 2018, the United States Pharmacopeial Convention (“USP”) issued a statement that it will not develop a new monograph for a biologic unless

FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

Hogan Lovells
USA
April 18 2018

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies

States Stepping into the Breach on Drug-Pricing Transparency

FisherBroyles LLP
USA
April 17 2018

In recent months President Trump, Food and Drug Administration Commissioner Scott Gottlieb, and Health and Human Services Secretary Alex Azar have all

FDA to Consider Approval of Botanical (not synthetic) CBD Drug

Duane Morris LLP
USA
April 17 2018

On Thursday April 18, 2018, at 8:00AM-12:30PM EST, an FDA advisory panel will consider whether to recommend or not recommend approval of GW

Industry objects to FDA's position on soy protein and heart health

DLA Piper
USA, Canada
April 17 2018

In a statement filed with the FDA on March 19, the Center for Responsible Nutrition, which represents the US dietary supplement industry, took issue

Capitol Hill Healthcare Update

Baker & Hostetler LLP
USA
April 16 2018

Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised

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