The U.S. Food and Drug Administration has created a complex regulatory regimen to ensure the safety of products offered to consumers. It also helps mitigate the risk for manufacturers by mandating that they adhere to these stringent requirements. Making the Right Choice The enterprise software selected for manufacturing medical devices and pharmaceutical products is of…
Pharma Execs Face the Feds
The leaders of seven major pharmaceutical companies have been called to testify before the Senate Finance Committee, on the topic of drug prices. The committee is led by Senators Chuck Grassley of Iowa and Ron Wyden of Oregon, who argue that prescription drug costs have climbed too high and the rate at which prices are…
Jazz Pharmaceuticals Announces FDA Approval of Sunosi for Excessive Daytime Sleepiness
FDA Approves First Treatment for Postpartum Depression
Allergan Announces FDA Approval of AVYCAZ for Pediatric Patients
FDA Approves Dupixent for Moderate-to-severe Atopic Dermatitis in Adolescents
Understanding the FDA’s Priority Review Voucher System
In 1984 the FDA passed the Orphan Drug Act1 in an effort to push the industry to pursue the treatment of rare diseases that afflict less than 200,000 patients a year in the U.S. Under the original Orphan Drug Act, companies were eligible for several extra years of marketing exclusivity, without generic competition, if they were able…
