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To meet a requirement of the 21st Century Cures Act, the FDA is seeking comments for a report on the patient safety and best practices impact of nondevice software functions. Read More
Precision Nuclear of Virginia landed a Form 483 following a March 22 to 25 inspection of its Roanoke, Va., facility where FDA officials observed multiple quality lapses. Read More
The FDA’s review of proposed instructions for use (IFU) for a new drug, biologic or combination product will focus on accuracy and consistency with the agency-approved prescribing information, according to a final labeling guidance issued yesterday. Read More
With an option for future acquisition of CathWorks, Medtronic has announced that it will invest $75 million and immediately begin co-promotion of CathWorks’ FFRangio System in the U.S., Europe and Japan. Read More
A class action suit alleging deceptive marketing of several of Sanofi’s pain relief products will move forward following a federal district judge’s ruling Tuesday. Read More
Viatris, formerly Mylan, now must pay out a settlement of $264 million to consumers, insurers and pension funds who sued the company over steep price spikes for EpiPen, which is used to quickly administer epinephrine to treat potentially fatal allergic reactions. Read More
Devicemaker CooperSurgical, a division of CooperCompanies, was slapped with a five-observation Form 483 for manufacturing problems primarily focused on its intrauterine device (IUD) Paragard T380A copper contraceptive. Read More