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The HHS arm that oversees the discounted drug pricing program has made some improvements to its operations since 2011 but it lacks regulatory authority to make other needed changes. Read More
Following Hospira’s recall last month of sterile sodium bicarbonate injections, the FDA has extended the expiration dates for more than 90 lots to help alleviate a critical shortage of injectable drugs. Read More
The FDA is launching a voluntary pilot program for manufacturers, distributors, and dispensers to help develop package-level tracing systems required by 2023 under the Drug Supply Chain Security Act. Read More
Any major changes to the way the 340B drug discount program is regulated and overseen will require action from Congress, experts told a House subcommittee Tuesday. Read More
The FDA is planning to modernize its recruitment and hiring practices to fill the several hundred vacancies plaguing the agency and attract more scientific talent. Read More
Unable to resolve persistent manufacturing problems, New Jersey-based drugmaker Pacira Pharmaceuticals is ending production of its DepoCyt chemotherapy drug and closing the California plant where it is made. Read More
Eli Lilly & Co. settled with several generic companies to resolve pending litigation over a unit dose patent for Cialis (tadalafil), delaying potential ANDA competition. Read More