RAPS

Dissolution Testing and Acceptance Criteria: FDA Finalizes Guidance

The US Food and Drug Administration (FDA) on Wednesday released final guidance for sponsors on when a standard release test and criteria may be used in lieu of extensive method development and ...
RAPS

FDA Guidance Provides Framework for Testing and Labeling Scored Drug Tablets

The US Food and Drug Administration (FDA) has published a new final guidance document on the criteria that sponsors of new and abbreviated drug applications (NDA/ANDA) should use to evaluate tablet ...

Patients urged to check bottles after FDA announces drug recall

The U.S. Food and Drug Administration has announced a nationwide recall of thousands of bottles of a commonly prescribed blood pressure medication after testing revealed a potential problem that could ...
Today

Xanax Recalled Nationwide For Failing FDA Quality Control Standards

A specific lot of the widely prescribed anti-anxiety drug Xanax has been recalled nationwide for not passing quality control tests concerning the time the pills take to dissolve, according to the Food ...
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Popular Cholesterol Drug Recalled For Failing 'Dissolution Specifications', What Does This Mean?

Over 141,000 bottles of popular cholesterol medication, Atorvastatin Calcium Tablets, have been recalled as it "failed dissolution specifications". This means the drugs did not pass a solubility test ...