FDA Law Blog: Biosimilars

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. This is another area in which FDA works with industry to try to ensure voluntary compliance from regulated entities. By John W.M.

Compliance 59

Compliance Online Pharmacies Clinical Trials FDA 59

Policy Prescription

MAY 28, 2021

The NeedyMeds host describes PSM as a “not-for-profit organization focused entirely on researching the danger of counterfeit drugs in America and educating the public about how to stay safe from them.”. and licensed by your state board of pharmacy.” Safdar, the executive director of the Partnership for Safe Medicine (PSM).

Pharmacy 52

Pharmacy Licensing Licensing Online Pharmacies 52

Policy Prescription

APRIL 1, 2022

This epic counterfeit drug debacle had nothing to do with the personal importation of less expensive prescription drugs or foreign online pharmacies. pharmacies and wholesalers allegedly flouting the rules. However, to do that, the regulations must prevent the creation of fake DSCSA pedigrees.

Pharmacy 40

Pharmacy Licensing Licensing Drugs 40