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Impax Laboratories says the FDA has inspected its Hayward, Calif. manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. Read More
The FDA has released a final guidance allowing it to destroy certain drug imports valued at $2,500 or less that have been refused admission into the country in an attempt to boost the integrity of the drug supply chain. Read More
European drugmakers are pressing regulators to streamline the conditional marketing authorization pathway for drugs that fulfill unmet needs, saying the current system is slower than the standard authorization process. Read More
A pair of U.S. senators are renewing efforts to crack down on pay-for-delay pharmaceutical deals, reintroducing the Preserve Access to Affordable Generics Act Wednesday. Read More
The FDA is clarifying when drugmakers can seek dispute resolution above the divisional level, citing five regulatory actions that are appropriate for a formal dispute resolution request. Read More
The primary efficacy endpoint in clinical trials for uncomplicated gonorrhea should be a negative culture at the infection site three to seven days after receiving antibacterial drug therapy, the FDA says. Read More