China To Get Tougher On Recalls Beginning In May
Executive Summary
More stringent recall rules in China will see the maximum penalty for failure to carry out a mandatory recall rise from three times the value of a medical device, to up to ten times its value.
You may also be interested in...
China Proposes Stricter Rules And Higher Penalties For Recalls
The China Food and Drug Administration wants to expand the scope of products subject to recall and increase the penalties for wrongdoers.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
Outlook Turns To Marketing Strategy After Scoring EU First For Ophthalmic Bevacizumab
Outlook Therapeutics’ intravitreally injected Lytenava has won the thumbs up from the European Medicines Agency. The company is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.