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This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
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
With much of the cannabis oriented media focusing on the flurry of adult use bills and opportunities, it is easy to overlook that many states are doubling down on their medical marijuana infrastructure. For instance, over...more
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
The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...more
On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of the centralised procedure (“the guidance...more