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August 25, 2009 

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Six Steps to Successful FDA GMP Inspections
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Validation and Use of Excel® Spreadsheets in Regulated Environments
With FDA's
Dennis Cantellops

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Labcompliance News, August 2009

FDA Commissioner Announces Six Steps to Improve Enforcement

In a presentation at the Food and Drug Law Institute (FDLI) the new FDA commissioner, Margaret Hamburg announced changes in FDA's enforcement practices. The planned changes have also been published in a press release and comprise six major steps:

  1. Set post-inspection deadlines.
  2. Take responsible steps to speed the warning letter process.
  3. Work more closely with FDA’s regulatory partners.
  4. Prioritize follow-up on warning letters and other enforcement actions.
  5. Be prepared to take immediate action in response to public health risks.
  6. Develop and implement a formal warning letter “close-out” process.”

FDA's New Enforcement Program will Begin on September 15, 2009

The program had already been announced by the new commissioner Margaret Hamburg in early August. It will support public health protection by facilitating the timely issuance of warning letters and other regulatory actions. The program establishes a timeframe for the submission and agency review of post-inspection responses to inspectional observations that are communicated to a firm through issuance of a FDA 483 form. For example, FDA only allows 14 days to respond to a 483 form inspectional observations, otherwise it will not taken into consideration for warning letters. The purpose of this program is to optimize FDA resource utilization, facilitate the timely issuance of warning letters, and promote prompt correction of violations. To read more details, download the Federal Register notice as published on August 11, 2009. 

FDA Inspection Package Version 4 Released 

Labcompliance has developed a new release of it's popular FDA Inspection Package. It includes more SOPs, an new 85 pages Inspection Survival, most recent FDA guidelines and the complete audio seminar presentation on FDA inspections. It is ideally suited to prepare your department, your site, and your entire organization for FDA inspections in the U.S. and international countries. It addresses FDA's new enforcement practices starting in Sept 2009 and includes SOPs for Responding to 483's and Warning letters. For more information and ordering click here.

FDA Launches New Center for Tobacco Products 


On August 19, 2009, US FDA launched its new Center for Tobacco Products in an historic effort to curb the hundreds of thousands of deaths caused by those products each year. The Center will oversee the implementation of the Family Smoking Prevention and Tobacco Control Act signed by President Obama in June 2009. The FDA’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, and establishing and enforcing advertising and promotion restrictions.

New FDA Guidance for Control of Melamine Contamination 

The Food and Drug Administration announced in a Federal Register notice of August 7, 2009, the availability of a guidance for industry entitled ‘‘Pharmaceutical Components at Risk for Melamine Contamination.’’ This guidance provides recommendations that will help pharmaceutical manufacturers of finished products, repackers, other suppliers, and pharmacists who engage in drug compounding to better control their use of at-risk components that might be contaminated with melamine. The guidance can be downloaded from the FDA website.

New FDA Guidance on Postmarketing Studies and Clinical Trials

The Food and Drug Administration announced in a Federal Register notice of July 15, 2009, the availability of a draft guidance for industry entitled ``Postmarketing Studies and Clinical Trials--Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the act) authorizing FDA to require certain postmarketing studies and clinical trials for prescription drugs and biological products approved under the act or the Public Health Service Act (the PHS Act). This draft guidance provides information on the implementation of the new provisions. The new guidance can be downloaded from the FDA website.

New FDA Guidance on Impurities in Drug Substances

The Food and Drug Administration announced in a Federal Register of July 15, 2009, the availability of a guidance for industry entitled ``ANDAs: Impurities in Drug Substances,'' which is a revision of a guidance for industry of the same name that published in November 1999. The guidance provides recommendations for applicants on what chemistry, manufacturing, and controls (CMC) information to include regarding the reporting, identification, and qualification of impurities in drug substances produced by chemical synthesis when submitting original abbreviated new drug applications (ANDAs); drug master files (DMFs), including type II DMFs; and ANDA supplements for changes in the synthesis or processing of a drug substance. The guidance can be downloaded from the FDA Website

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the SOP: Laboratory Failure Investigations . To download your free copy, go to the FDA Inspection Package website.  Scroll down and click on the corresponding ICON on the left (offer expires on July 31, 2009). Labcompliance offers more than 100 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

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