As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of ...
The recently enacted Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) requires FDA to adopt regulations governing Good Manufacturing Practices (“GMPs”) for the manufacture of cosmetic ...
Looking to clarify its expectations on manufacturer responses following inspections, the FDA earlier this year unveiled, for ...
The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.
The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to ...
Good Manufacturing Practice (GMP) is a system or protocol for ensuring product safety and consistency according to quality standards. GMP is important in all manufacturing industries, though it is ...
Manufacturers are usually subjected to a diverse variety of regulations typically established by international and regional bodies. Failure to comply can result in the loss of authorization and ...
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