FDA's Draft Guidance Pediatric Uses of Medical Devices

Sunday, March 2, 2014 10:36:45 AM Europe/Berlin

The Food and Drug Administration (FDA) is issuing a final rule amending the

regulations on premarket approval of medical devices to include requirements relating to the

submission of information on pediatric subpopulations that suffer from the disease or condition that

a device is intended to treat, diagnose, or cure.


See --> Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act

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FDA's Pre-Sub replaces pre-IDE

Sunday, March 2, 2014 10:25:47 AM Europe/Berlin

Established in 1995, the pre-IDE program has been a successful resource for both medical device applicants and FDA and has become the most commonly used mechanism for requesting FDA’s feedback prior to a premarket device submission.

Intentially, this program was designed to provide applicants a tool to obtain FDA feedback on planed IDE applications prior to their submission. This new guidance ioncludes a broader scope of the program.


See --> Requests for Feedback on Medical Device Submissions. The Pre-Submission Program and Meetings with FDA

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Is FDA turning into a profit center?

Sunday, August 28, 2011 9:41:44 AM Europe/Berlin

The FDA commissioner, Dr. Margaret “Peggy” Hamburg went into action after nomination with changes to be applied at the FDA. The commissioner today is under high pressure by the congress on the one hand and the public on the other hand.  The economic crisis in the US as well as the forthcoming 2012 election of the US president has put enforcement on top of the FDA’s agenda.  It is recognized by industry that FDA is much more quickly posting a warning letter after an unsatisfactory inspection. Consent decrees will not be fare a way any longer if persistent violations are proven.  Currently there are many cases in the industry of well known companies which struggle well knowing that a warning letter or consent decrees will have a critical impact on reputation, sales, product availability on the market as well as companies share price.  As a consequence it is even more important for the industry to meet the FDAs expectations by having founded and implemented a robust GMP Quality Management System and to take inspection preparation and management back to the top priority goals of the company.

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Risk Management for Pharmaceutical Industry

Thursday, July 28, 2011 5:49:34 PM Europe/Berlin

It is clear know that Risk Management for the pharmaceutical industry is mandatory and there is no way around.

If you look at actual EMA and FDA inspection findings risk based decision taken is expected by the industry.
As an annex of EU GMP Guide, ICHQ9 was approved in November 2005 and implemented in the US, EU and Japan.

The expectation of making risk based decisions in a planned and formal manner which meet agency expectations is key for the whole pharmaceutical industry. But this is not only important to survive regulatory inspections but will give high value to your business and your company.

This will put you in a position from daily fire fighting to proactively mange your particular risks. It is company responsibility to decide on the right level of quality risk management by using well know risk management tools and ranking the risk with methods like FMEA (Failure mode and effect analysis).

These tools, the process and application are very well described in the publication from 31.Jannuary 2011.

Click here for ICHQ9

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GHTF - Reportable Events during Pre-Market Clinical Investigations

Wednesday, July 20, 2011 10:42:58 AM Europe/Berlin

Global Harmonization Task Force GHTF proposed new document for reportable events during pre-market clinical investigations.

You find the document here:

GHTF Reportable events during Pre-Market Clinical Investigations

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FDA announced new Guidance Docs for 2011

Thursday, March 17, 2011 9:59:32 PM Europe/Berlin

FDA CDER announced new Guidance Agenda to be update existing Guidance regulations or to publish new Guidance in calendar year 2011.

There are a number of really interesting topics on the agenda like:

  • Bioanalytical Methods Validation
  • Development of Drugs in Combination
  • Contract Manufacturing
  • Control of Components
  • Control of Highly Potent Compounds
  • Importation of Active Pharmaceutical Ingredients (API) for Use in Human Drugs
  • Medical Gases, General CGMP
  • Non-Penicillin Beta-Lactam Contamination 
  • Outsourcer Pharmacy Operations Compliance Policy Guide
  • Pharmaceutical Component Quality Control
  • Pharmaceutical Manufacturing Statistics
  • Prevention and Control of Viral Contamination
  • Compliance Policy Guide Section 490.200 for FDA Staff: Parametric Release - Drug Products Terminally Sterilized by Moist Heat 
  • Good Pharmacy Compounding Practices for Sterile Drug Products

See the full agenda on the CDERs Homepage.

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Information about OTC and drug Product recalls published by FDA

Saturday, February 5, 2011 5:13:43 PM Europe/Berlin

Recently the FDA published Good Manufacturing Practices for holding and distribution of drug products and over the counter products (OTC) on its "Question and Answers" web page. FDA provides answers on recalls in general and differences of drug product recalls and OTC product recalls.

Read more on the FDA's web page


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