We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA issued final guidance Wednesday on dissolution testing for immediate-release solid oral dosage form drugs containing high solubility substances. Read More
CMS announced a new policy late Tuesday that will allow Medicare Advantage plans to use a “step therapy” approach to control prescription drug costs for patients in an effort to meet the administration’s promises of lower drug prices and better Medicare negotiation. Read More
An FDA advisory panel voted Wednesday in favor of the safety and efficacy of Paratek’s two NDAs for omadacycline tablets and omadacycline injection as treatments for community-acquired bacterial pneumonia (CAPB) and acute bacterial skin and skin structure infections (ABSSSI). Read More
An FDA advisory committee voted Tuesday in favor of the safety and effectiveness of Insmed’s NDA amikacin for treatment of nontubercuolous mycobacterial (NTM) lung disease for patients with limited treatment options. But the panel rejected it for adult patients as a whole. Read More
The FDA Tuesday finalized its recommendations on how drug sponsors submitting applications should control elemental impurities in their drug products. Read More