FDA Law Blog: Biosimilars

AUGUST 21, 2023

During a routine inspection in June 2022, Drug Enforcement Administration (“DEA”) diversion investigators determined that People’s Rx pharmacy violated recordkeeping requirements, improperly dispensed controlled substances to practitioners for office stock and issued prescriptions without authorization. 16, 2023 ( DOJ Press Release ).

Pharmacy 52

Pharmacy Regulations Production Laboratories 52

FDA Law Blog: Biosimilars

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. Gaulkin & Riëtte van Laack — On May 16, the U.S.

FDA 45

FDA Compliance Regulations Production 45

The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Food and Drug Administration for the products.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Wenzel S.

Trials 40

Trials Production Clinical Trials Government 40