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FDA
NEJM The Private Sector Discoveries Account for 79–90% of…
The discovery and development of new drugs, medicines, and vaccines to solve unmet medical needs is an extremely long and…
FDA to Expedite Medical Device Approval
This week, the Food and Drug Administration (FDA) announced a new plan that would speed up the approval of innovative medical…
Shortage of Injection Treatments Looms over ACA
As the Obama Administration and federal agencies begin preparing for implementation of key provisions of the Affordable Care Act…
Risk Evaluation and Mitigation Strategies (REMS) Summary
According to a recent assessment by the Tufts Center for the Study of Drug Development (CSDD), “drug developers, healthcare…
FDA Boot Camp — Hooah
As the regulatory landscape for pharmaceutical and medical device companies continues to rapidly change, and as key provisions of…
FDA Seeks Input on Transparency Initiative
In June 2009, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg launched FDA’s Transparency Initiative to help…
FDA Updates 510K Approval Process for Medical Devices
This week, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced new actions for the…
FDA Transparency Initiative: Improving Transparency to Regulated Industry
In June 2009, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg launched FDA’s Transparency Initiative to help…
FDA to Hold MDUFA Meetings
The Food and Drug Administration (FDA) will be holding its first patient and consumer advocacy group meeting on the…
FDA Transparency Guidance — Advisory Committees
The Food and Drug Administration’s (FDA’s) advisory committees play an essential role in FDA’s activities to protect and promote…