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Food, Drug and Cosmetics Law Reporter

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Everything you need to know about Food and Drug Regulations.

Full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics.

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Medical Devices Reporter

Access the full text plus expert analysis of all laws and regulations governing the classification, approval, manufacture, and marketing of all medical diagnostic, and radiological devices.

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Countries may seek exemptions from BSE restrictions

Upon application and review, the FDA may designate a country as not subject to bovine spongiform encephalopathy (BSE, “mad cow disease”) restrictions applicable to human food and cosmetics manufactured from, processed with, or that otherwise contain: specified risk materials, the small intestine of cattle (unless the distal ileum is removed), material from nonambulatory disabled cattle, or mechanically separated beef. Amending the definition of “ prohibited cattle materials” in two previous interim final rules, the FDA concurred with previously submitted comments that it was not necessary for all BSE-related restrictions to apply to human food and cosmetics regardless of a country's BSE status.

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Clinical trial databank certification guidance issued

A draft guidance for industry, clinical researchers and FDA staff about clinical trial information and documents submitted to the FDA that typically need not be certified under Section 402(j) of the Public Health Service Act has been issued by the FDA for comment. The draft guidance is called “ Guidance for Sponsors, Industry, Researchers, Investigators, and FDA Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of the Public Health Service Act (PHS Act), Added by Title VIII of the Food and Drug Administration Amendments Act of 2007.”

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