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Regulatory Oversight Applications Prescription Drugs

ArentFox Schiff

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

ArentFox Schiff on

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more

Troutman Pepper Locke

Georgia to Become First State in the Nation to Allow Medical Marijuana in Pharmacies

Troutman Pepper Locke on

The Georgia Board of Pharmacy has begun accepting applications from independent, licensed pharmacies for authorization to dispense authorized medical marijuana products, and nearly 120 pharmacies reportedly have agreed to...more

Hogan Lovells

Complementary Medicines: the way forward

Hogan Lovells on

According to a recent report published by Grand View Research, Inc., it is expected that by 2026, the global complementary and alternative medicine (CAM) industry will generate over USD 200 billion. The CAM industry, which...more

Hogan Lovells

The FDA now offers cGMP Declarations

Hogan Lovells on

The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...more

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