Food Drug & Devices – January 2010
I. Agency Developments FDA tobacco manufacturers documentation requirements A draft guidance to assist tobacco product manufacturers and importers submit required documentation to the FDA has been...
View ArticleFood Drug & Devices – February 2010
I. Agency Developments Food safety and medical regulations highlight 2011 budget request The FDA requested $4.03 billion to promote and protect public health as part of the fiscal year (FY) 2011 budget...
View ArticleFood Drug & Devices – April 2010
I. Drug and Biologics Developments Electronic prescriptions of controlled substances to address errors Effective June 1, 2010, practitioners will be permitted the option of writing prescriptions...
View ArticleFood Drug & Devices – May 2010
Topic of the Month: In response to last year’s enactment of the Tobacco Control Act (Public Law 111-31; 123 Stat. 1776), the FDA published a number of documents regulating or clarifying concerns....
View ArticleFood Drug & Devices – June 2010
Announcing the New CCH Health Reform Toolkit In response to the new health reform laws—Patient Protection and Affordable Care Act and Health Care and Education Reconciliation Act of 2010—Wolters Kluwer...
View ArticleFood, Drug & Devices – July 2010
Topic of the Month: In July the FDA began to address the issue of food labeling with the creation of a docket for restaurants involved in the process of establishing nutrition content on menus for...
View ArticleFood, Drugs & Device Update – March 2011
Topic of the Month: With the widespread devastation in northern Japan caused by a magnitude 9.0 earthquake on March 11, 2011, and the resulting damage at the Fukushima Daiichi nuclear power plant, the...
View ArticleFood, Drugs & Device Update – April 2011
Topic of the Month: In Mid-April, the White House unveiled a multi-agency plan aimed at reducing the “epidemic” of prescription drug abuse in the U.S. — including an FDA-backed education program...
View ArticleWeight control drug product reclassified
Benzocaine would be reclassified from its previously proposed monograph status (category I) for over-the-counter (OTC) weight control use to nonmonograph status in a proposed rule by the FDA. An...
View ArticleMedication guides in outpatient settings, draft guidance
Medication Guides should be dispensed in outpatient settings, even when the drug is dispensed to a healthcare professional for administration to the patient, the first time the drug is dispensed, and...
View ArticleUser fee waiver request draft guidance revised
User fee waiver or reduction requests were revised in a draft guidance published by the FDA for applicants considering the process. Titled “User Fee Waivers, Reductions, and Refunds for Drug and...
View ArticleSafety labeling changes draft guidance issued
The FDA would send a safety labeling change notification letter to application holders if a safety labeling change was necessary under a draft guidance published by the agency. Titled “Safety Labeling...
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