Food Drug & Devices

Safety labeling changes draft guidance issued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a safety labeling change notification letter to application holders if a safety labeling change was necessary under a draft guidance published by the agency.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 Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act,” the draft document provides information on the implementation of the new provisions, […]

User fee waiver request draft guidance revised

User fee waiver or reduction requests were revised in a draft guidance published by the FDA for applicants considering the process. Titled “User Fee Waivers, Reductions, and Refunds for Drug and Biological Products,” the revised draft guidance describes the types of waivers and reductions permitted under the user fee provisions of the FDC Act, and […]

Medication guides in outpatient settings, draft guidance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to the patient, the first time the drug is dispensed, and if the Medication Guide is materially changed, according to a draft guidance published by the FDA. Titled “Medication Guides— Distribution Requirements and Inclusion in […]

Weight 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 approved new drug application (NDA) or abbreviated new drug application (ANDA) for the marketing of OTC weight control products containing benzocaine would be required, because agency […]

Food, 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 designed to reduce the misuse and misprescribing of opioids. Opioids are synthetic versions of opium that are used to treat moderate and severe pain. […]

Food, 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 FDA noted that its current screening at U.S. borders will be augmented with radiation screening of shipments. On March 22, 2011, to […]

Food, 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 consumers. The agency noted that in subsequent months it would collect information on the nutrition effort in order to promulgate […]

Food 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 introduces the CCH Health Reform Toolkit, a complete suite of electronic workflow tools for navigating and understanding the near 3000 pages of legislation into easy […]

Food 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.  Exceptions for outdoor tobacco advertisement regulations enforcement, set to begin June 22, 2010, were issued in order to allow the agency more time […]

Food 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 for controlled substances electronically under a Drug Enforcement Administration (DEA) interim final rule amending regulations implemented by the Controlled Substances Act. The DEA revised the regulations to […]