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With a Drug Supply Chain Security Act (DSCSA) implementation date set for 2023, the FDA has published four guidances designed to bolster efforts to identify and trace drugs as they move through the supply chain, including a final guidance clarifying product identifier requirements for drugmakers. Read More
FDA Acting Commissioner Janet Woodcock said the FDA urgently needs to revamp its inspection program in testimony before the Senate Appropriations subcommittee on the agency’s fiscal 2022 budget request. Read More
Merck is withdrawing its accelerated approval application to the FDA for its blockbuster cancer drug Keytruda (pembrolizumab) for third-line treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, following disappointing study results. Read More
Prices for cancer drugs are higher when first introduced on the U.S. than in three wealthy European countries — Germany, Switzerland and England — and their prices tend to increase faster than inflation in the U.S. while decreasing in inflation-adjusted terms in the latter three nations, a new study found. Read More
Pharmaceutical companies, pharmacy benefits managers (PBMs) and hospitals are high on the target list of the Federal Trade Commission (FTC) as the agency moves to deepen its antitrust investigations into bad actors in certain industries over the next decade. Read More
The House Committee on Appropriations has advanced legislation to increase nonuser-fee funding to the FDA by $257 million to $3.45 billion in fiscal year 2022 and the fast-moving bill is on its way to the House floor with a vote expected in July — but there may be a few catches. Read More
Many drugmakers complained to ERG about being unable to regularly meet with FDA officials to discuss patient experience data during product development. Read More
From the lessons learned in the COVID-19 pandemic, the FDA intends to push for greater use of master protocols, decentralized trials and digital health technology moving forward, Acting Commissioner Janet Woodcock and other top agency officials said yesterday. Read More
There were fewer U.S. drug shortages in 2020 but more work is needed to improve the supply chain’s resiliency, the FDA said in a new report to Congress. Read More
The Centers for Medicare and Medicaid Services may be demanding transparency in pricing from hospitals, but it isn’t working very well, according to GoodRx. Read More