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Clinical trials of drug products intended for topical application should assess the risk of contact dermatitis, a new FDA draft guidance says. Read More
The FDA detailed how and when drug sponsors should evaluate the nonclinical toxicity of drug metabolites, in a final guidance released Friday. Read More
India’s pharmaceutical agency reported last week that the country has enough active pharmaceutical ingredients to fuel its manufacturing operations for three months. But the rest of the world may not be as fortunate, with some APIs from the two largest global suppliers — China and India — now interrupted. Read More
The FDA said it does not plan to take enforcement action, under certain conditions, against outsourcing facilities that use four bulk drug substances that will no longer be eligible for mixing, diluting or repackaging following the agency’s transition of nearly 100 biological products from NDAs to BLAs on March 23. Read More
New Mexico Governor Michelle Lujan Grisham signed into law legislation Wednesday that makes the state’s out-of-pocket costs for insulin the lowest in the country. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) sent its first warning letter of the year to Outlook Pharmaceuticals of Cincinnati, Ohio over a sponsored link for its ADHD treatment ProCentra (dextroamphetamine sulfate). Read More
The FDA released final guidance yesterday on the transition of insulin and other biological products from new drug applications (NDAs) to biologics license applications (BLAs) as the March 23 transition date looms. Read More