JD Supra12d
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
pharmaphorum8d
Navigating the regulatory pathway with innovative products
Another major challenge is when a drug is in its final stage and ready for the approval process; there may not be enough reliable information on the regulatory pathways to get it approved by the ...
pharmaphorum13d
Innovative Regulatory Pathways Summit
Innovative Regulatory Pathways Summit will bring together leading ... to increase communication and collaboration with the FDA, to enable efficient drug development. Accelerated drug development ...
Food1d
What does FDA’s freeze mean for the food industry?
While a pause on federal health agencies is nothing new during presidential transitions, the Trump Administration’s ...
CNET16d
FDA Finally Bans Red Dye No. 3: What You Need to Know
The US Food and Drug Administration announced this month that it's effectively banning Red No. 3, the controversial artificial red dye found in food and drinks that's been linked to cancer. The ...
Targeted Oncology6d
FDA Expands PATHWAY HER2 (4B5) Test to Include HER2-Ultralow Status
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
JD Supra29d
FDA Furthers Efforts to Improve the Accelerated Approval Pathway through New Draft Guidance on Confirmatory Trials
Accordingly, the successful completion of these confirmatory studies converts a drug’s accelerated approval ... a much stronger driving force than the regulatory motivation established in ...
Business Wire29d
Paige Adds to Regulatory Portfolio with New FDA Clearance
“This FDA clearance highlights our dedication ... “Our ability to navigate complex regulatory pathways and deliver products that meet stringent regulatory requirements reinforces our position ...