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The Reagan-Udall Foundation unveiled an online directory of dozens of pharmaceutical company policies on expanded access to investigational therapies. Read More
Eighteen patients filed a lawsuit against Merck, claiming its shingles vaccine Zostavax caused them to contract shingles and, in two cases, to develop persistent nerve pain related to the virus. Read More
A new party platform unveiled by Democrats on Monday includes new measures to lower the cost of prescription medications, target drug industry gouging and require drugmakers to justify price increases. Read More
The agency plans to use the pilot to assess industry’s ability to meet the DSCSA’s requirements, including identifying illegitimate products and preventing diversion. Read More
The PTO’s Patent Trial and Appeal Board rejected five Mylan challenges to patents held by UCB Pharma and Pfizer covering the overactive bladder treatment Toviaz. Read More
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