| 13 February 2013
A new report just published by the US Institute of Medicine (IOM) and sponsored by the US Food and Drug Administration (FDA) finds that global regulators and regulatory systems need to do more to Read More...
| 28 August 2012
Australia’s Therapeutic Goods Administration (TGA) has released revised guidance on the evidence required to support indications made for over-the-counter (OTC)medicines.Therevised version now permits Read More...
| 16 August 2012
A new piece of UK legislation that replaces most of the Medicines Act of 1968 and more than 200 statutory instruments has come into effect, regulators announced this week.The 14 August passage of the Read More...
| 15 May 2012
A new paper exploring counterfeit and substandard medicines shows the presence of even a minimally-developed regulatory program can have a profound impact on ensuring consumers have access to genuine, Read More...
| 10 April 2012
The European Medicines Agency (EMA) held a two-day workshop in March 2012 on the use of medicines in older persons.The workshop saw 34 presentations covering a wide range of perspectives on the Read More...
| 30 March 2012
Pharmacist and seasoned regulatory professional Max Sherman has written on science and medical topics for years, and began writing for RAPS’ magazine Regulatory Affairs Focus
, as it was called at the time, more than a decade ago. Over the years, his writing has covered a range of diverse and occasionally unusual subjects related to the practice of medicine, medical research, regulatory issues, biology, chemistry and other related disciplines.
He has taught university-level classes on quality and regulatory affairs, and his writing is often educational, whether it’s a history lesson about quack medical devices, a biology lesson about bats or a peek into processes of the US Food and Drug Administration (FDA), it’s almost impossible not to learn something new reading one of Sherman’s articles. At the same time, he writes in an accessible and entertaining style.
RAPS has now published a collection of Sherman’s articles from Regulatory Focus
and other publications, entitled From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories
. I recently had a chance to talk with him about the book and his writing. Following is an edited transcript of our conversation. Read More...
| 14 March 2012
UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released a new report introducing “new, proportionate approaches to regulation of medicines” that aims to keep in place the same Read More...