Remove Books Remove FDA Remove Pharmaceutical Companies
article thumbnail

The Issue with Reissue: PTE Edition

The FDA Law Blog

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. FDA has already been there , of course, with respect to 180-day exclusivity.)

article thumbnail

Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.

FDA 65
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

The Importance of Modernizing Your Email Marketing Campaigns

Pharma Marketing Network

Personalization and Compliance in Modern Email Marketing Regulations in the pharmaceutical industry require marketers to walk a fine line between engagement and compliance. Fortunately, modern email marketing platforms come equipped with features that help ensure every message aligns with HIPAA, CAN-SPAM, and FDA guidelines.

HIPAA 52
article thumbnail

Barriers are limiting UK childhood vaccination, say doctors

pharmaphorum

Skip to main content Tuesday 1 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

article thumbnail

STAT+: Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more

STAT

You could also take a moment to curl up with a good book or perhaps enjoy some scrumptious food. Food and Drug Administration Commissioner Marty Makary said the agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the U.S. See you soon.

FDA 66
article thumbnail

STAT+: FTC warns drugmakers they can face legal action over improper patent listings

STAT

The Federal Trade Commission warned pharmaceutical companies they could face legal action if they improperly list patents for brand-name medicines in a Food and Drug Administration registry, the latest effort by the federal government to scrutinize patent moves by drugmakers. Continue to STAT+ to read the full story…

article thumbnail

Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

Gregory’s industrial career spans an employment history with several major pharmaceutical companies. IPQ International Pharmaceutical Quality. He obtained his BS in Chemistry from St Xavier College, MS in Analytical Chemistry from Governors State University and a PhD in Analytical Chemistry from Northern Illinois University.