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FDA
FDA: House Republicans Question Generic Drug Rulemaking Process
A large group of House Republicans is once against raising questions about the U.S. Food and Drug Administration's (FDA)…
FDA Social Media Guidance: Correcting Independent Third-Party…
The Food and Drug Administration (FDA) released two new guidances for drug and device companies looking to communicate…
FDA Social Media Guidance: Presenting Risks and Benefits With Social…
The Food and Drug Administration (FDA) released two new guidances for drug and device companies looking to communicate…
FDA Launches – Open FDA
In early June, the U.S. Food and Drug Administration (FDA) launched openFDA, a new initiative designed to make it easier…
Collaboration: FDA Adds Johns Hopkins and UCSF-Stanford to its Centers of…
The Food and Drug Administration (FDA) must attempt to match its safety and efficacy regulations with the speed of…
FDA CDER Guidance Agenda for Remainder of 2014
As we continue to cover the FDA and Congress begins considering an overhaul to the FDA's regulatory framework, it might…
FDA Draft Guidance: Best Practices in Developing Proprietary Drug Names
Medication errors account for an estimated 7,000 deaths annually, according to a 1999 Institute of Medicine (IOM)…
FDA to Consider Expanding Scientific Exchange
At the 2014 FDLI Annual Conference, senior officials at FDA noted that the agency is not taking lightly industry's concerns…
FDA Relaxing Controls on Imported Products for 13 Pharmaceutical Companies
The Food and Drug Administration (FDA) is loosening the regulatory controls for 13 pharmaceutical companies that will…
FDA Seeks Comment on New Draft Guidance for Biosimilars: “Clinical…
The Affordable Care Act amended the Public Health Service Act (PHSA) to include an abbreviated approval pathway for biological…