Clinical Research Solutions
On Wednesday, September 29th, EMA announced the implementation of new measures indented to replace, reduce, and refine animal use in the development, manufacturing, and testing of human and...
Clinical Research Solutions
On Tuesday, April 14th, FDA released two product-specific guidance documents for chloroquine phosphate tablets and hydroxychloroquine sulfate tablets, two drugs being investigated as potential...
Clinical Research Solutions
On Wednesday, April 1, 2020, FDA issued a statement asking all companies to stop selling all forms of Zantac (ranitidine). Background On Friday, September 13, 2019, the FDA announced that “some...
Clinical Research Solutions
On August 7th, the U.S. Government Accountability Office (GAO) published its report on generic drug applications. In the report, GAO comments on the number of products approved on the first review...
Clinical Research Solutions
On, Tuesday, June 11th, 2019, the FDA issued a final guidance document entitled “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.” The guidance was published less than...
Clinical Research Solutions
In a new draft guidance released by the FDA on July 11th, the promise was made for access to quantitative data on maximum daily exposure levels (MDEs) of excipients by October 1, 2020. This will go a...
Clinical Research Solutions
On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS...
Clinical Research Solutions
Earlier this month, FDA announced the approval of Spravato (esketamine) nasal spray. The product is to be used in conjunction with an oral antidepressant and is indicated for the treatment of...
Clinical Research Solutions
On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted...
Clinical Research Solutions
On Wednesday, February 6th, FDA issued a letter to health care providers to increase the awareness of an association between all breast implants and Breast Implant Associated-Anaplastic Large Cell...