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Former FDA Commissioner Robert Califf is likely to be the Biden administration’s nominee to replace acting commissioner Janet Woodcock and take up the role of the agency’s permanent head once again. Read More
The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH) for makers of drugs and drug-device combination products. Read More
They contend that serving as head of a large industry trade association is disqualifying since McMurry-Health has represented the interests of hundreds of FDA-regulated companies. Read More
As COVID-19 drug shortages continue to plague the global supply chain, Sanofi’s arthritis drug Kevzara (sarilumab) has become the latest casualty. Read More
The FDA’s newly launched novel excipient review pilot program aims to identify possible safety issues before they can delay a drug’s application, said a senior official within the Center for Drug Evaluation and Research (CDER). Read More
More than two dozen advocacy groups have sent a letter to President Biden, urging him not to nominate Michelle McMurry-Heath, CEO of the Biotechnology Innovation Organization (BIO), for the role of FDA commissioner. Read More
Just two days in advance of an independent advisory committee meeting to discuss whether or not the FDA should grant Emergency Use Authorization (EUA) to Moderna’s COVID-19 booster shot, the FDA has released documents saying Moderna hadn’t met all of the agency’s criteria to support use of a booster. Read More
The companies are accused of failing to warn patients about the possible contamination of their ranitidine products with N-nitrosodimethylamine (NDMA). Read More
Holdouts among party centrists and warring legislation could derail Democrats’ efforts to include drug pricing reform in the $3.5 trillion Build Back Better Act — ahead of a self-imposed Oct. 31 deadline for passage. Read More
In its final guidance, NICE said the list price for Adakveo was confidential as was the discount the NHS would be receiving for offering the drug. Read More