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March 06, 2020
European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.
The action involves allowing specific National Institute for Occupational Safety and Health-approved respirators not regulated by FDA to be used in healthcare settings to increase the number of respirators available in the United States.
March 05, 2020
FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.
A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.
March 02, 2020
States, hospitals, and insurers support manufacturing arrangements to ensure access to affordable medicines.
Emergency action to protect patients and the drug supply may have long-term implications.
A brief overview of three notable cases of adverse drug reactions.
EU regulators have accelerated their efforts to use the mass of data emerging from the lifecycles of drugs as an effective basis for both the development and control of medicines.
February 28, 2020
With the first announced drug shortage tied to the coronavirus outbreak, FDA emphasizes urgency for monitoring drug supply chain.
February 21, 2020
As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.