Regulators weigh PIP silicone test results, poised for unified response
This article was originally published in Clinica
The results of the genotoxity tests performed by French regulatory agency Afssaps on the silicone filler of the infamous PIP breast implants are now known, Clinica has learned. They are due to be published, together with recommendations for the follow-up of PIP implantees, by the end of this month.
You may also be interested in...
The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”
CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.
Anticipating a July approval of its cantharidin formulation, Verrica says it is poised to implement a buy-and-bill model for a clinician-administered product with an addressable market of 6 million.