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FDA
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FDA Draft Guidance: Best Practices in Developing Proprietary Drug Names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FDA Seeks Comment on New Draft Guidance for Biosimilars: “Clinical…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…
FDA: Draft Guidance for Industry Fees for Human Drug Compounding…
The US Food and Drug Administration (FDA) has published a new guidance document intended to establish user fees to fund…
FDA Proposed Rule: Medical Device Classification Procedures
As recently reported, the U.S. Food and Drug Administration (FDA) is proposing to simplify the way it classifies and reclassifies…
FDA Proposes Expedited Approval Process for Medical Devices
The US Food and Drug Administration (FDA) proposed a new program to expedite medical device approvals for patients whose serious…
FDA Finalizes Public Availability of Advisory Committee Members’ Financial…
The Food and Drug Administration (FDA) announced a new conflict of interest guidance entitled Public Availability of Advisory…