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Effective Jan. 1, drugmakers can now seek accelerated drug approvals in the UK using the newly launched Innovative Licensing and Access Pathway (ILAP). Read More
HHS has made it known that pharma companies are required to offer 340B discounts for covered drugs even when they’re distributed by contract pharmacies, speaking out after several big drugmakers began withholding them. Read More
HHS has ordered the FDA to “cease further collection efforts” related to the Over-the-Counter Drug Monograph User Fee Program and has withdrawn the agency’s Dec. 29 Federal Register notice on user fee rates. Read More
The FDA made the right call in strongly advising against using a half-dose regimen of Moderna’s COVID-19 vaccine to stretch supply and vaccinate more Americans, members of the agency’s vaccine advisory panel told FDAnews. Read More
FDA has published two guidances focused on maintaining compliance with the agency’s mislabeling regulations as well as how best to name new drugs so that consumers can avoid medication errors. Read More
A final guidance published Dec. 17 indicates the FDA will limit the kinds of questions generic drug sponsors may submit to the agency to get feedback during drug development. Read More
By the end of 2022, drug, device and biologic product sponsors that are required to submit a risk evaluation and mitigation strategy (REMS) will have to do so electronically, the FDA said in a final guidance issued late last month. Read More
The FDA is working on a report tied to a two-day meeting held in December to discuss its pilot program on pharmaceutical supply chain interoperability, as well as other efforts to modernize the drug supply chain in the U.S. Read More
India’s Bharat Biotech plans to produce 700 million doses of its newly approved vaccine this year, the company’s managing director Krishna Ella said Monday. Read More
The World Health Organization (WHO) has granted the Pfizer/BioNTech COVID-19 vaccine an Emergency Use Listing — the first such listing by the standard-setting body since the pandemic began. Read More
Tier 1 over-the-counter monograph order requests involve adding a new ingredient or indication, while Tier 2 requests relate to lesser changes. Read More