Tag: drug approval process

April 30, 2018

Key Stock Catalysts in the FDA Drug Application Process

Pharmaceutical and biotech companies in the US must follow a standard process to advance a new drug candidate through nonclinical...
December 6, 2017

How Do Medical Devices Get Approved?

We examine how the FDA classifies, regulates and approves medical devices.
August 31, 2017

SteadyMed Stock Price Declines Following FDA Refusal Letter

For the second time this week the FDA sends refusal letter for a medical candidate.In doing so, it sent SteadyMed's...
July 31, 2017

Generic Drugs Lead the FDA's Competition Action Plan

On his first three months as commissioner of the Food and Drug Administration, Scott Gottlieb has already taken significant steps...
June 19, 2017

Isodiol International inc. commences approval process for its pharmaceutical products through the Brazilian Health Regulatory Agency (ANVISA)

Isodiol International Inc.(CSE: ISOL) (OTC: LAGBF) (FSE: LB6A.F) (the “Company” or “Isodiol”) a global cannabis innovator specializing in the development...
March 16, 2017

FDA User Fee To Double In New US Budget

Keeping with his promise to change the FDA, Trump reveals an increase of user fees in the budget.
March 14, 2017

Trump's FDA Nominee Aligns With Changes To The Agency

Dr. Scott Gottlieb would be heading the FDA after a confirmation vote by the American Senate.