Safety labeling changes draft guidance issued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a safety labeling change notification letter to application holders if a safety labeling change was necessary under a draft guidance published by the agency.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, […]

Food, Drug & Devices Update – October 2010

Subscribers to the Food, Drugs, and Cosmetics and Medical Devices Reporter will now have access to the full text of the Public Health Service Act (PHSA) on IntelliConnect, instead of select excerpts.  Access to this title is especially important after enactment of health care reform in 2010, since the introduction of biosimilar pathway, drug labeling, […]

Food Drugs and Devices Update – September 2010

Topic of the Month: Medical products development would be improved under a joint pilot program between the FDA and the Centers for Medicare and Medicaid Services.  Citing inefficient use of agency resources in product approvals, as well as general confusion to developers, the parallel development would potentially reduce the time to market and national coverage […]

Food, Drug & Devices – August 2010

Topic of the Month: An outbreak of Salmonella Enteritidis (SE) that sickened hundreds of people across the country led the FDA to a recall of shell eggs. On August 13, a major shell egg producer voluntarily conducted a nationwide recall of shell eggs on 3 of its 5 farms. Further epidemiologic and traceback information led […]

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 […]

Food 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 – a 23 percent increase over the agency’s current $3.28 billion budget. According to the FDA, the budget request reflects the agency’s resolve […]

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 published by the agency. The draft guidance titled “Tobacco Health Document Submission” provides information on who should submit documents and what should be included. The FDA had previously […]