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The FDA issued guidance for sponsors developing chronic obstructive pulmonary disease (COPD) treatments, clarifying how to efficiently use the St. George’s Respiratory Questionnaire a patient-reported outcome measure assessment tool. Read More
The FDA last week previewed an upcoming pilot project that offers initial reviews of protocols for clinical trials with highly complex, innovative designs. Read More
In what Commissioner Scott Gottlieb called “a significant milestone” in the FDA’s new policy for oversight of drug compounding , the agency released draft guidance Friday on how it will develop a list of bulk drug substances, known as the 503B list, that outsourcing facilities can use in compounded drugs. Read More
The FDA said it will not enforce recordkeeping requirements for combination product applicants who use the agency’s Adverse Event Reporting System and Electronic Medical Device Reporting System before July 31, 2019. Read More
He said the agency had enhanced its operations at international mail facilities to intercept illegal narcotics such as fentanyl and is expanding the agency’s cybercrime investigative unit, which specializes in disrupting online networks that manufacture and sell counterfeit drugs. Read More
Under the settlement deal, Endo will pay $60 million to the direct purchasers in the litigation, while Watson will pay $71 million and Teikoku will pay $35 million. Read More
Endo International and two other drugmakers agreed to pay $270.8 million to settle class-action lawsuits over a pay-for-delay arrangement for a generic of Endo’s Lidoderm lidocaine pain patch. Read More
The House passed its version of federal right-to-try legislation, sending it for re-consideration by the Senate, which passed a similar bill last August. Read More