New Guidances, Investigations to Shape Drug Manufacturing, Regulation in 2014
The Food and Drug Administration plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices. There will be more advice on establishing a quality system approach to current good manufacturing practice (GMPs) and on quality agreements with contract manufacturers, according to 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.
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.