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  1. Risk Management for Pharmaceutical Industry

    Risk Management for Pharmaceutical Industry 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 Read more...
  2. FDA's Draft Guidance Pediatric Uses of Medical Devices

    FDA's Draft Guidance Pediatric Uses of Medical Devices The Food and Drug Administration (FDA) is issuing a final rule amending the regulations on premarket approval of medical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 Read more...
  3. FDA announced new Guidance Docs for 2011

    FDA announced new Guidance Docs for 2011 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 Read more...
  4. GHTF - Reportable Events during Pre-Market Clinical Investigations

    GHTF - Reportable Events during Pre-Market Clinical Investigations 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 Read more...
  5. FDA's Pre-Sub replaces pre-IDE

    FDA's Pre-Sub replaces pre-IDE 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 Read more...
  6. Information about OTC and drug Product recalls published by FDA

    Information about OTC and drug Product recalls published by FDA 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...
  7. Is FDA turning into a profit center?

     Is FDA turning into a profit center? 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 Read more...

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