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The Canadian government is not happy with the FDA’s decision to allow the state of Florida to import certain Canadian prescription drugs in bulk, and neither is the powerful U.S. pharmaceutical industry trade group PhRMA. Read More
Two significant changes in the FDA’s final guidance on updating ANDA labeling are details on how to obtain information on changes to reference listed drug (RLD) labeling and how to submit revised ANDA labeling. Read More
Less than two months after its announced investigation of secondary T-cell cancers in patients who received chimeric antigen receptor (CAR)-T cell immunotherapy cancer treatments, the FDA is mandating label updates to include a boxed warning, the agency’s most serious drug safety alert. Read More
The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SME) in the pharmaceutical sector, including updates to reflect new EU regulations, guidance for working with technology and data and collaborating outside the EU. Read More
A boxed warning has been added to the labeling for Prolia (denosumab) based on FDA review of information on the risk of severe hypocalcemia, very low blood calcium levels, in patients with advanced chronic kidney disease. Read More
CDRH set a new record last year, says its latest annual report, granting marketing authorization to 124 novel devices, excluding emergency use authorizations (EUAs), the highest in the more than 40-year history of the center. Read More
The FDA has warned Novartis that its direct to consumer TV ad for its breast cancer drug Kisqali (ribociclib) makes false or misleading representations about the drug’s efficacy, sending the company an untitled letter. Read More
Inspections will be much more streamlined once the FDA completes its sweeping reorganization, according to Deputy Commissioner Janet Woodcock. Read More
High drug prices and barriers to generic drugs are the targets of Sens. Amy Klobuchar (D-Minn.) and Bernie Sanders (I-Vt.) who are seeking answers from pharmaceutical manufacturers. Read More