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Firms that manufacture single-entity or co-packaged combination products will be regulated under rules governing pharmaceutical products as well as medical devices, according to a draft guidance released as part of the FDA’s pharmaceutical current good manufacturing practice (cGMP) initiative.
Cutting-edge scientific and engineering knowledge, as well as the best principles of quality management, need to be introduced into the drug manufacturing process to respond to the challenges of new discoveries and ways of doing business, the FDA said in a final guidance on process analytical technologies (PAT).
Maintaining the highest degree of environmental control, limiting the exposure of sterile product elements, optimizing process flow and designing equipment to prevent entrainment of lower quality air in clean rooms is essential for preventing contamination in the sterile drug manufacturing process, according to an FDA final guidance.
Drugmakers need to start building quality into their products and eschew the idea that testing alone can be relied upon to ensure product quality, according to the FDA’s draft guidance on implementing a quality systems (QS) approach to drug manufacturing.
Limiting the exposure of sterile product elements, maintaining the highest degree of environmental control, optimizing process flow and designing equipment to prevent entrainment of lower quality air in clean rooms is essential for preventing contamination in the sterile drug manufacturing process, according to an FDA final guidance.
Drugmakers should use cutting-edge scientific and engineering knowledge, coupled with the best principles of quality management, in their manufacturing process to respond to the challenges of new discoveries and ways of doing business, the FDA said in a final guidance on process analytical technologies (PAT).
The FDA will not, for the most part, enforce 21 CFR Part 11 rules related to computerized systems used in clinical trials, according to a draft guidance issued Sept. 29.
Pharmaceutical firms need to start building quality into their products and eschew the idea that testing alone can be relied upon to ensure product quality -- that's the overarching philosophy of the FDA's draft guidance on implementing a quality systems approach to drug manufacturing.
The cost of bringing a new drug to market -- estimated to be between $800 million and $1.7 billion -- is a major barrier to firms considering investing in innovative higher-risk drugs or therapies for diseases that are uncommon or that predominantly afflict the poor, according to a new FDA report.
Pharmaceutical or device manufacturers seeking FDA approval for combination products may be eligible to reduce or waive agency user fees when they submit more than one application, according to a draft guidance from the agency.