Clinical Research Solutions
FDA’s Expedited Programs Explained
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Clinical Research Solutions
EMA to Marketing Authorization Holders (MAHs): Submit Type I Variations for 2021 by end of Month
On Friday, October 29, 2021, the EMA published a statement providing marketing authorization holders (MAHs) recommended submission dates for 2021 variations in order to meet the regulatory deadlines....
Clinical Research Solutions
FDA Revokes Emergency Use Authorization of IVD Device for COVID-19 Detection
On Wednesday, October 27th, FDA revoked Life Technologies Corporation’s Emergency Use Authorization (EUA) for its TaqPath COVID-19 MS2 Combo Kit 2.0. Background On August 2, 2021, FDA issued an EUA...
Clinical Research Solutions
EMA Takes Steps to Minimize Animal Testing During Product Development
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...
Regulatory Sciences
The Key to Understanding Pricing and Reimbursement in the Nordics
It is easy to think that when you finally receive market approval for your drug, you have reached the finish line. However, what many do not realize is that there is still a final hurdle that can be...
Clinical Research Solutions
FDA Issues Product-Specific Guidance Documents for Chloroquine Phosphate and Hydroxychloroquine Sulfate
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
FDA Requests Zantac Products be Removed from the Market
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
Only 12% of Generic Drugs Reviewed Were Approved in the 1st Review Cycle, says GAO Report
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
FDA Monographs and Current Regulations for Sunscreen Products
Over-the-counter (OTC) drugs are defined by the FDA as drugs that are safe and effective for use by the general public without seeking treatment by a health professional. Currently, there are more...
Clinical Research Solutions
FDA Finalizes Guidance on Premarket Tobacco Product Applications for E-Cigarettes
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...