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The FDA is proposing to exclude three substances from its 503B Bulks List of substances for outsourcing facilities to use in compounding drugs — including one that’s the subject of an Endo lawsuit against the agency. Read More
For products that have a short shelf life and cannot be stockpiled, suppliers should have plans for products to be transported via air freight. Read More
The Senate passed an amendment Thursday to require drugmakers to list prescription drug prices in direct-to-consumer ads in an effort to promote lower prices through increased transparency. Read More
A federal appeals court affirmed last week that Novartis did not engage in antitrust violations to protect a patent on its leukemia drug Gleevec (imatinib). Read More
A coalition of health care stakeholders called on the FDA to issue final guidance on interchangeable biosimilars to help promote drug price competition, saying the agency’s failure to finalize its January 2017 draft guidance created “significant uncertainty.” Read More
Excluding certain patients “limits the ability of a trial to generate data that are relevant to the actual users of the drug,” the experts said. Read More
According to the DOJ, the two doctors distributed or prescribed controlled substances such as Oxycodone, Percocet and steroids illegally to undercover agents. Read More