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February 10, 2021
FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.
Representatives of industry organizations discuss crucial business, regulatory, science-based issues facing the industry.
February 08, 2021
FDA considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus.
February 05, 2021
FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.
February 02, 2021
FDA puts applications on hold as the agency limits alternative oversight methods.
February 01, 2021
With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies.
January 29, 2021
The European Medicines Agency has recommended granting conditional marketing authorization for AstraZeneca’s COVID-19 vaccine.
FDA published guidance that includes risk-based recommendations for minimizing the potential transmission of COVID-19.
January 25, 2021
Woodcock will serve as acting commissioner of FDA, taking over for Stephen Hahn, FDA’s previous acting commissioner.
January 22, 2021
Verquvo is a soluble guanylate cyclase stimulator for the reduction of the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure.