Refine your search
12,759 results found
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…
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…
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…
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…
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FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program
On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program…
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…
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…
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On April 8, 2022, the U.S. Food and Drug Administration (“FDA”) released a draft guidance document titled “Cybersecurity in Medical Devices: Quality…
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…
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…
