Containment, Filler and Pharmacy - Clinical Research Informer

New Section 804 Drug Import Rule Does Not Allow Foreign Versions of FDA-Approved Drugs

Pharmacy Checkers

NOVEMBER 12, 2020

A foreign version of an FDA-approved drug is a finished pharmaceutical that has the active ingredient contained in the FDA-approved version and is approved in another country. But the Canadian drug includes a different binder or filler as inactive ingredients. There’s a different inactive ingredient.

FDA Approval

FDA Approval Drugs Filler Manufacturing

TLC Announces Full Patient Enrollment in EXCELLENCE Trial of TLC599 for Osteoarthritis PainOn-schedule completion of enrollment despite COVID-19 pandemic; unique trial design evaluates safety and efficacy of single & repeat doses

The Pharma Data

DECEMBER 27, 2020

The US Department of Justice announced in October that opioid maker Purdue Pharma would plead guilty to fueling the nation’s opioid crisis in a $8 billion settlement, and sued Walmart recently for unlawfully dispensing controlled substances through its pharmacies, certifying the gravity of the opioid crisis. About TLC599. Source link.

Trials

Trials Clinical Trials Clinical Trials Containment

New Section 804 Drug Import Rule Does Not Allow Foreign Versions of FDA-Approved Drugs

TLC Announces Full Patient Enrollment in EXCELLENCE Trial of TLC599 for Osteoarthritis PainOn-schedule completion of enrollment despite COVID-19 pandemic; unique trial design evaluates safety and efficacy of single & repeat doses

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