article thumbnail

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. Food and Drug Administration (FDA) to first grant a suitability petition. Both bills – S.

article thumbnail

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. Food and Drug Administration (FDA) to first grant a suitability petition. Both bills – S.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “genericdrugs of the biopharma world.

article thumbnail

Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

article thumbnail

Shkreli is sued for monopolizing Daraprim. But what ever happened to Azar’s single source drug import plan?

Pharmacy Checkers

Pasted from the AG’s press release : Attorney General James Sues ‘Pharma Bro’ Martin Shkreli And Vyera Pharmaceuticals For Illegally Monopolizing Life-Saving Drug. Basically, the charge is that the Vyera took myriad actions to prevent a lower-cost generic drug from coming to market.

Drugs 54
article thumbnail

Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

Pharmacy Checkers

Founded in 2002, and launching its website in 2003, PharmacyChecker provides consumers with online pharmacy verification and comparative drug price information to help them make the best decisions for themselves and their families on how to afford prescription drugs. counterparts.