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Sponsors of drugs to improve glycemic control in patients with Type 2 diabetes should evaluate safety data from longer-term studies and consider patients with comorbid conditions, a new FDA draft guidance says. Read More
In a blow to Genentech’s blockbuster cancer drug Herceptin, a federal appeals court refused to temporarily suspend sales of Amgen’s biosimilar while a lower court considers a patent infringement challenge. Read More
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trials of drug products intended for topical application should assess the risk of contact dermatitis, a new FDA draft guidance says.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