FDA Law Blog: Biosimilars

JANUARY 22, 2024

The tools it uses to accomplish that mission include those designed to help regulated entities that want to follow best public health practices, like guidances, public notifications, and requests for information. OC also has input into FDA’s more forceful enforcement measures, like warning letters, import alerts, and consent decrees.

Compliance 59

Compliance Online Pharmacies Clinical Trials FDA 59

Policy Prescription

MAY 28, 2021

The Canadian drug supply is pretty safe…” However, standards for a walk-in pharmacy are not applicable to online pharmacies in Canada, which are unregulated and can sell “unlicensed” medications. and licensed by your state board of pharmacy.” Were the statements from PSM’s Executive Director accurate?

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. Where’s the FDA?

Pharmacy 40

Pharmacy Licensing Licensing Drugs 40