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Companies that manufacture single-entity or co-packaged combination products must adhere to manufacturing regulations governing both pharmaceutical products and medical devices, according to a draft guidance released Sept. 29 as part of the FDA’s pharmaceutical cGMP initiative.
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idea that testing alone can be relied upon to ensure product quality -- that's the overarching philosophy of the FDA's draft guidance on implementing a quality systems approach to drug manufacturing.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 FDA will soon start employing a risk-based approach for prioritizing site inspections for certain pharmaceutical products, the agency announced in a final report on its current good manufacturing practice (cGMP) initiative.
Brand pharmaceutical companies are over-profiting from the difference in how the FDA and the Centers for Medicare & Medi-
caid Services (CMS) view authorized generics, according to the Generic Pharmaceutical Association (GPhA).
The FDA has issued a final guidance document that details the vaccine labeling process, describes the agency’s review of childhood vaccine labeling under section 314 of the National Childhood Vaccine Injury Act and discusses the type of data FDA examines when determining the adequacy of vaccine labeling.
The FDA last week released its long-awaited final report on the pharmaceutical current good manufacturing practice (cGMP) initiative and while the information package is aimed primarily at drugmakers, it did contain two draft guidances -- one on combination products and another on computerized systems used in clinical trials -- that have a direct bearing on devicemakers.
Manufacturers of pharmaceuticals or devices that seek FDA approval for a combination product may be eligible to reduce or waive agency user fees when they submit more than one application, according to a draft guidance from the agency.
The FDA will relax enforcement of 21 CFR Part 11 rules related to computerized systems used in clinical trials, according to a draft guidance issued last week.