FDA Issues 22 Warning Letters to Web site Operators

December 1, 2009

FDA’s Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers.

Reason:

None of the Web sites are for pharmacies in the United States or Canada.

What did the agency issued?

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law.

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Guidance: Patient-Reported Outcomes

September 15, 2009

Source:  http://www.fdanews.com/ext/files/06d-0044-gdl0001.pdf

This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials.
It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling.

PRO instruments provide a means for measuring treatment benefits by capturing concepts related to how a patient feels or functions with respect to his or her health or condition.

The concepts, events, behaviors, or feelings measured by PRO instruments can be either readily observed or verified (e.g., walking) or can be non-observable, known only to the patient and not easily verified (e.g., feeling depressed).


The (FDA) is proposing to amend its postmarket medical device reporting (MDRs) regulation

August 28, 2009

The Food and Drug Administration (FDA) is proposing to amend its postmarket medical device reporting regulation to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs) to the agency in an electronic format that FDA can process, review, and archive.

Benefit/ Advantage

  1. Mandatory electronic reporting would improve the agency’s process for collecting and analyzing postmarket medical device adverse event information.
  2. The proposed regulatory changes would provide the agency with a more efficient data entry process that would allow for timely access to medical device adverse event information and identification of emerging public health issues.

FDA is also announcing a draft guidance document that provides recommendations on how to prepare and submit electronic MDRs to FDA in a manner that satisfies the requirements of this proposed regulation.

Date to Submit:

November 19, 2009. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 (the PRA) by September 21, 2009.

Addresses to Submit:

You may submit comments, identified by Docket No. FDA–2008–N–
0393 and/or RIN number 0910–AF86, by any of the following methods

Electronic Submissions
Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments

Written Submissions

Submit written submissions in the following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA– 305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852

Instructions:

All submissions received must include the agency name and Docket No(s). and Regulatory Information Number (RIN) (if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to http:// http://www.regulations.gov, including any personal information provided.

Source: – http://edocket.access.gpo.gov/2009/pdf/E9-19683.pdf

Also I have found some webinars which are related to MDR medical device reports which can be helpful

  1. Complaint Handling, MDR’s & Recalls
  2. Medical Device Complaints, MDR’s and Recalls
  3. Development and Audit of Complaint Handling and MDR Processes

Source:- http://www.complianceonline.com


Tight Regulation Over Cigarettes: Got Approved

June 15, 2009

More than four decades after the surgeon general declared smoking a health hazard, the Senate on Thursday cleared the final hurdle to empowering federal officials to regulate cigarettes and other forms of tobacco for the first time.

The Congressional Budget Office has estimated the new law would reduce youth smoking by 11 percent and adult smoking by 2 percent over the next decade, in addition to reductions already achieved through other actions, like higher taxes and smoke-free indoor space laws.

Law gives power to FDA:

  • Law would give the F.D.A. power to set standards that could reduce nicotine content and regulate chemicals in cigarette smoke.
  • The law also bans most tobacco flavorings, which are considered a lure to first-time smokers.
  • The law would also tighten restrictions on the marketing and advertising of tobacco products.
  • Colorful ads and store displays will be replaced by black-and-white-only text.

Beginning next year, all outdoor advertising of tobacco within 1,000 feet of schools and playgrounds would be illegal.

What Cigarette Makers required to do:-

Cigarette makers will be required to stop using terms like “light” and “low tar” by next year and to place large, graphic health warnings on their packages by 2012.

Source: The New York Times


FDA revises ICH Q8 guidance

June 11, 2009

The FDA has revised its guidance on ICH Q8, adding an annex that clarifies the original document and adds the principles of quality by design (QbD).

The US Food and Drug Administration’s (FDA) guidance states that different drug delivery methods will have varying CQAs, such as adhesion properties for transdermal patches, but raw materials such as excipients and intermediates are common factors.

Using the framework devised by the International Conference on Harmonisation (ICH) the guidance details the importance of identifying CQAs and using knowledge of them to guide product and process development.

Source: in-pharmatechnologist


FDA issues final guidance on ICH Q10

April 9, 2009

The FDA has provided a model for implementing the ICH Q10 quality control system in its final guidance, which is intended help manufacturers adapt processes throughout a product’s lifecycle.

By building upon good manufacturing practices (GMP) the International Conference on Harmonization’s (ICH) Q10 attempts to provide a comprehensive model for an effective quality management system.

The implementation of aspects of ICH Q10 not covered by GMP is optional. However, by adopting the additional processes outlined in the US Food and Drug Administration’s (FDA) guidance manufacturers should benefit from the innovation and continual improvement that are central tenets of ICH Q10.

In addition unlike GMP ICH Q10 explicitly covers all aspects of a product’s lifecycle, from development through to discontinuation, and is designed to strengthen the link between pre- and post-commercialization manufacturing activities.

Within this framework the FDA identifies three main objectives: achieve product realisation, establish and maintain a state of control and facilitate continual improvement.

To achieve these goals the FDA recommends companies use knowledge and quality risk management, with the guidance detailing how these ICH Q10 “enablers” should be used.

The complete guidance can be found here .

Source: In-PharmaTechnologist.com


On the Road Again: FDA’s Mobile Laboratories

March 31, 2009

mobile_labs_011FDA’s mobile laboratories are part of the agency’s nationwide network of laboratories, where scientists are continually testing food and drugs for contaminants.The chemistry mobile lab is shown here on the road near its base of operations in Jefferson, Ark.

This modified 44-foot trailer is one of three units that make up FDA’s chemistry mobile laboratory.

This 34-foot command center, outfitted in a modified motor home, is part of FDA’s chemistry mobile laboratory. Two other units, the sample preparation unit and the analytical unit, complete the lab.

An FDA scientist, who doubles as a driver, loads cable covers into the chemistry mobile laboratory. The covers protect communication cables, water hoses, and other cabling necessary to run the lab equipment.

Source: FDA News