Tag Archives: FDA

Five Steps to Data Integrity

Siegfried Schmitt offers some steps that manufacturing companies can take to ensure data integrity. In general, media tend to report on the most serious data integrity violations uncovered by regulators. Often when companies find similar issues through their own internal investigations, they remain confidential and unreported. It would, therefore, be presumptuous to assume violations reported on […]
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FDA Announces Diagnostic Testing Measures

FDA has announced it is taking steps to ensure that certain diagnostic tests are accurate, consistent and reliable. The Agency is first issuing a final guidance on the development, review and approval or clearance of companion diagnostics, which are commonly used to detect certain types of gene-based cancers. Second, it will publish a risk-based oversight […]
Posted in FDA, Gene therapy, Regulatory, Safety | Also tagged , | Leave a comment

Will the Supreme Court Spur OTC Contraceptive Development?

One piece of fall-out from the recent Hobby Lobby decision by the U.S. Supreme Court is to generate talk of Republicans backing development of a nonprescription contraceptive pill. Conservative commentators supported this strategy as a way for Republicans to deflect Democratic charges of a GOP “war on women” and access to safe and effective birth […]
Posted in FDA, healthcare, Op-Ed, Regulatory | Also tagged , | 1 Comment

FDA’s Patient Outreach: Finding Ties that Bind

Is the FDA doing enough to incorporate the patient perspective in the drug review process? This was the key question considered at a panel of regulatory experts held at last month’s annual BIO International Convention in San Diego. The consensus: while FDA deserves high marks for effort, both in reconciling the diversity of patient organization […]
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Making the Most of Social Media (Within FDA’s New Guidelines)

By Ken Ribotsky. Pharmaceutical companies have begun using social media for business needs and promotion, yet have been hesitant to become too engaged since the FDA’s stance on social media activity remained unclear. But now that we know the FDA’s specific guidelines for pharma companies’ actions online, it’s time for brands to consider diving into […]
Posted in compliance, E-Media, FDA, Guest Blog, Op-Ed, Regulatory, social media | Also tagged | 1 Comment
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