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The FDA denied a request by Canadian drugmaker Apotex to rescind its approval of a competing ANDA for a potassium chloride oral solution submitted by Novel Laboratories — granted on the same day Apotex qualified for 180-day competitive generic therapy (CGT) exclusivity. Read More
On the heels of CMS’ proposed rule to require disclosure of drug prices in TV ads, the FDA issued draft guidance Tuesday on presenting efficacy and risk information in direct-to-consumer (DTC) promotional materials and drug ads. Read More
“Each CDM system represents a trade off on where to set the balance between the efforts invested in data management and data analysis. Where the emphasis is placed is likely to have an impact on the speed of studies,” the EMA said. Read More
“In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections,” said FDA Commissioner Scott Gottlieb. Read More
The FDA released draft guidance Monday on how sponsors of treatments of rare diseases can get more from their pre-investigational new drug meetings with the agency. Read More
The FDA might be willing to extrapolate clinical data for targeted therapies even if sponsors can’t recruit patients with a specific genetic variant of the disease being treated, the agency says in the first of two guidance documents issued Monday. Read More
The Centers for Medicare and Medicaid posted a proposed rule Monday that would require drugmakers to include the list price of their products on TV ads, aiming to implement one element of the Trump administration’s blueprint for lowering drug prices. Read More
The complaint alleges that Westminster knew there were problems with the drugs for months but didn’t recall them until after the FDA forced its hand. Read More