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Category Archives: Regulatory
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50 Years after Thalidomide: Why Regulation Matters
Fifty years ago, the vigilance of FDA medical officer Dr. Frances Kelsey prevented a public health tragedy of enormous proportion by ensuring that the sedative thalidomide was never approved in the United States. As many remember, in the early 1960’s, reports were coming in from around the world of countless women who were giving [...]
Posted in Regulatory Tagged FDA, Frances Kelsey, Margaret Hamburg, Regulatory, Thalidomide, Wayne Kubick Leave a comment
Should AERS Reports Do More For Patients?
Since its inception in 2007, the Food and Drug Administration Amendments Act (FDAAA) has required the FDA to “conduct regular, bi-weekly screenings of the Adverse Event Reporting System (AERS) database and post a quarterly report….[on] potential signals of a serious risk identified.” Although the act calls for the report of any AEs, it advises prescribers [...]
Lessons for World CTs from European Medical Device Failings
At first sight, the deficiencies of European controls on breast implants might seem to have little to offer in the way of guidance for effective clinical trials on medicines.
But once again, European regulators are under the harsh glare of scrutiny, and—once again, as in the recent Mediator case, when questions were raised over patient injury [...]
FDA Releases Three Biosimilar Development Guidelines
After months of anticipation, the Food and Drug Administration issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies. The announcement came the same day that FDA officials discussed new user fees for biosimilars and generic drugs at a Congressional hearing. Three separate draft guidances map out the scientific considerations, quality [...]
Posted in Regulatory Tagged biosimilar development, biosimilar guidance, CDER, FDA, Jill Wechsler, Rachel Sherman Leave a comment
EU Questions Electromagnetic Radiation Limits
It is fashionable in many healthcare circles to denigrate the European Union for adopting a high-handed and inflexible approach to many of the complex issues that health policy is fated to cover. It is still more fashionable—indeed almost mandatory—to castigate the European Parliament, the EU’s self-styled representative of the people, for adopting an unrealistically cautious [...]
Posted in Regulatory Tagged electromagnetic radiation, European Parliament, European Union, MRI, Peter Liese, Peter O'Donnell Leave a comment
Quicker Review for Generics and Biosimilars on the Horizon
The FDA’s review process for new drugs is slow. That is not news. But if a new agreement between the agency and the industry is approved by Congress things might get a little quicker.
Also posted in CRO/Sponsor Tagged biosimiliars, FDA, generics, Tim Denman, user fees Leave a comment
Are Black Box Warnings Enough? Should FDA Do More?
According to a recent report from Medco Health Solutions (download here http://medco.mediaroom.com/), one in five insured Americans has taken at least one psychotropic medication in the past year. Overall, Americans have increased their intake of psychiatric medications by 22 percent (from 2001 to 2010), with women 45 and older showing the highest use of these [...]
Posted in Regulatory Tagged antipsychotics, Black Box Warnings, David Muzina, FDA, Kayda Norman, Medco, psychotropic medications, Regulatory Leave a comment
Happier New Year? Busier, Anyway
For those who—understandably—have better things to do with their time than study the inner workings of regulatory authorities, it may perhaps be helpful as another year opens to see at least a snapshot of what two of the principal authorities in the world consider as important upcoming business.
Posted in Regulatory Tagged EMA, european commission, London, New Year, Peter O'Donnell Leave a comment
New Anti-Falsification Regulations for EU QPs