Last week, FDA published a final guidance for pharmaceutical manufacturers that plan to incorporate physical–chemical identifiers (PCIDs) in solid oral dosage forms as an anticounterfeiting strategy. The guidance defines a PCID as “a substance or combination of substances possessing a unique physical or chemical property that unequivocally identifies and authenticates a drug product or dosage form.” PCIDs include inks, pigments, flavors, and molecular taggants. [Read more…]
Last week, FDA published a guidance titled Marketed Unapproved Drugs—Compliance Policy Guide, which describes the agency’s enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter (OTC) drug review. The document is a revision of the June 2006 guidance of the same name.
Because FDA lacks the resources to take immediate action against all illegally marketed products, it will give higher priority to enforcement actions that involve unapproved drug products in certain categories, including drugs with potential safety risks, and drugs that lack evidence of effectiveness.
Another high-priority category for FDA is health-fraud drugs. The guidance defines health fraud as “[t]he deceptive promotion, advertisement, distribution, or sale of articles . . . that are represented as being effective to diagnose, prevent, cure, treat, or mitigate disease (or other conditions), or provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes.” Drugs that present a direct risk to health will be the agency’s highest priority in this product category. [Read more…]
FDA’s 2011 Process Validation: General Principles and Practices guidance created a systemic shift in industry’s approaches to validation programs. The authors describe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.
In January 2011, FDA published its long-awaited guidance for industry on Process Validation: General Principles and Practices (1). For many in the pharmaceutical industry, the guidance created a systemic shift in the expectations of their validation programs. Although the new guidance aligns process-validation activities with the product life-cycle concept and with existing harmonized guidelines such as the International Conference on Harmonization’s Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System, it may have created as many questions for the industry as it has answered. In this article, the authors briefly describe the three-stage approach to validation that is outlined in the new guidance as well as implications for manufacturers regarding their current approaches to process validation. Specific emphasis is placed on questions surrounding industry implementation. [Read more…]
A new U.S. fee that is expected to significantly increase the cost of re-inspecting product suspected of a food-safety violation went into effect on Saturday.
As a result, the U.S. Food and Drug Administration has issued some clarification and relief on the collection of these fees, authorized under the Food Safety Modernization Act, which was signed into law by President Obama in early January.
The FDA will begin charging food importers a fee, based on an hourly rate, for any “re-inspection” of product, which is required when the FDA discovers a food-safety violation during an inspection. The fee is USD 224 per hour, USD 335 per hour if foreign travel is required.
The National Fisheries Institute on Saturday e-mailed an alert to its industry members summarizing the FDA’s guidance. And, to the relief of U.S. seafood importers, the FDA does not intend to bill any companies before 1 January, 2012, and fees will not be assessed if the original inspection or recall order occurred before 1 October, 2011. [Read more…]
The U.S. Food and Drug Administration today announced that it has completed two tasks required by the new Food Safety Modernization Act (FSMA). FDA has issued an anti-smuggling strategy, and issued draft guidance clarifying agency expectations on new dietary ingredients.
The FDA issued an anti-smuggling strategy developed by the Department of Health and Human Services (HHS) in coordination with the Department of Homeland Security (DHS) that will help to identify and prevent smuggled foods from entering the United States and posing a threat to national security and consumer safety.
“The Food Safety Modernization Act requires the agency to build a new food safety system,” said Deputy Commissioner for Foods Michael R. Taylor. “This new system, overall, will better leverage the resources of federal agencies and it will make industry an important partner in safeguarding the health of U.S. consumers.”