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Goodwin Procter LLP | USA | 13 May 2022

FDA Testimony Before the U.S. Senate Regarding Reauthorization of the Biosimilar User Fee Act

This week Patrizia Cavazzoni (Director, CDER), Peter Marks (Director, CBER), and Jeffrey Shuren (Director, CDRH) of the FDA testified before the…
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Bryan Cave Leighton Paisner LLP | USA | 12 May 2022

Supplemental Information on Dietary Supplements: Federal Proposal Aims to Establish Mandatory Dietary Supplement Database

In an aim to increase transparency in the U.S. dietary supplement industry, Senators Dick Durbin (D-IL) and Mike Braun (R-IN) recently introduced the…
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Greenspoon Marder LLP | USA | 12 May 2022

Big Candy and Big Food Companies Ask Congress To Intervene on Illicit Cannabis Packaging

Last year, Congress began working on new legislation to combat the amount of counterfeit goods being sold through e-commerce sites. The so-called…
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Keller and Heckman LLP | USA | 12 May 2022

FDA Works to Improve Supply of Formula Products

On May 10, 2022, FDA published a news release in which it highlighted its efforts to improve the supply of infant and specialty Formula products…
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Knobbe Martens | USA | 12 May 2022

FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program

On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program…
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Sheppard Mullin Richter & Hampton LLP | USA | 11 May 2022

Warning! FDA Issues Warning Letters for Products Containing Delta-8 THC

On May 4, 2022, the Food and Drug Administration (FDA) issued Warning Letters to five companies it asserts are illegally marketing products labeled…
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Keller and Heckman LLP | USA | 11 May 2022

FDA Issues Warning Letters to 11 Supplement Companies

On May 9, the FDA posted Warning Letters to 11 companies for selling adulterated dietary supplements that either contained new dietary ingredients…
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Ropes & Gray LLP | USA | 11 May 2022

FDA Updates Guidance on Cybersecurity Responsibilities for Medical Device Manufacturers

On April 8, 2022, the U.S. Food and Drug Administration (“FDA”) released a draft guidance document titled “Cybersecurity in Medical Devices: Quality…
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Hogan Lovells | USA | 10 May 2022

Demy-Colton panel explains importance of U.S. market access planning ahead of Phase III trials

Hogan Lovells has teamed up with Demy-Colton to host a special three-part webinar series focused on U.S. market access for life sciences firms…
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McCarthy Tétrault LLP | Canada | 10 May 2022

New Medicines Landscape in Canada & Abroad: PMPRB Outlines Trends in Pharmaceutical Approvals, Sales and Drug Pricing

On May 5, 2022, the Patented Medicine Prices Review Board (“PMPRB”) presented an Overview of the New Medicines Landscape in Canada. The presentation…
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