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British Prime Minister Theresa May has won a further delay from European leaders until Oct. 31 on the UK’s exit from the EU, leaving drugmakers no clearer about the ultimate impact of Brexit on the supply chain. Read More
The FDA issued a final rule on Thursday requiring OTC sanitizers with certain active ingredients to seek approval under an NDA or ANDA as a new drug. Read More
Gottlieb sought during his two-year tenure at the FDA to address the issue by indirect means, such as by speeding up reviews of generics to spur competition. Read More
If a drug’s side effects are reversible or preventable, for instance, regulators may require a REMS that ensures that prevention or counter-measures can be used quickly. Read More
“Thousands of illicit and dangerous products come from overseas each day, such as unapproved fentanyl products, counterfeit prescription drugs or fake over-the-counter products that look legitimate,” Gottlieb said. Read More
A federal grand jury in Virginia has indicted drugmaker Indivior for allegedly running a nationwide scheme to increase subscriptions of its Suboxone film (buprenorphine and naloxone) opioid dependence treatment. Read More
Those who defend the current drug rebate system are defending higher list prices and costs for customers, HHS Secretary Alex Azar said on Wednesday in a speech to independent pharmacists. Read More
Congress should eliminate copays for insulin rather than focus on the life-saving biologics’ list price, an executive with one of the nation’s largest drugmakers said Wednesday. Read More