FDA Outlines Agenda for New Guidances in 2014
FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.
The Food and Drug Administration plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices including more advice on establishing a quality system approach to current good manufacturing practice (GMPs) and on quality agreements with contract manufacturers. FDA listed proposed guidances in the 2014 guidance agenda for the Center for Drug Evaluation and Research.
Other documents will address use of cloud computing systems in manufacturing, interim GMPs for drug compounding outsourcing facilities, submission of field alert reports and biological product deviation reports, and electronic filing of information on manufacturing establishments.
Specifically related to chemistry, manufacturing and controls (CMC), FDA plans to provide advice on analytic procedures and methods validation, appropriate packaging for injectables drugs, CMC information in comparability protocols, evaluation of near infrared spectroscopy methods, CMC and other documentation for liposome drug products, and labeling vial fill size.
Further information is expected on developing biosimilars, including the hot topic of demonstrating interchangeability to a reference product. There also will be advice on developing pharmacology data, on labeling biosimilars, and on reference product exclusivity. Other guidances will clarify approaches for developing new analgesics, drugs for rare diseases, and treatments for chronic fatigue syndrome and infectious diseases. FDA also plans to clarify best practices in developing drug proprietary names and on distributing drug samples. And there will be advice on identifying suspect products and tracking drugs, as required by the Drug Quality and Security Act.
More guidance on Internet/social media communications is expected this year, one on presenting risk and benefit information in limited space, another on correcting independent/third party misinformation about a drug or medical device, and a third on appropriate use of website links. And a long-anticipated document on using the “brief summary” to disclose drug risk information may finally emerge.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
