Search results
Order by most recent / most popular / relevance
Results: 1-10 of 73
FDA seeks comment on 5 year strategic priority plan
- Reed Smith LLP
- -
- USA
- -
- October 15 2010
FDA seeks comments on the agency's draft document, "Strategic Priorities FY 2011-2015."
FDA listing of drugs with potential safety issues
- Reed Smith LLP
- -
- USA
- -
- February 26 2010
On February 18, 2010, the FDA posted updated listings of specific drugs that are being evaluated for potential safety issues based on a review of reports in FDA's Adverse Event Reporting System
FDA draft guidance on electronic source documents in clinical trials
- Reed Smith LLP
- -
- USA
- -
- January 13 2011
FDA has published a draft guidance entitled "Electronic Source Documentation in Clinical Investigations."
FDA issues advanced notice of new GLP rules for non-clinical studies
- Reed Smith LLP
- -
- USA
- -
- January 13 2011
Following a workgroup's conclusion that non-clinical studies should be conducted under a good laboratory practices (GLPs) quality system approach, FDA has decided to modify the existing GLP regulations for non-clinical studies
New Molecular Entity Postmarketing Safety Pilot Program
- Reed Smith LLP
- -
- USA
- -
- October 30 2009
FDA has completed the "New Molecular Entity Postmarketing Safety Evaluation Pilot Program" that began in January, 2007
Sebelius issues Section 1135 waiver
- Reed Smith LLP
- -
- USA
- -
- October 29 2009
On October 24, 2009, President Obama signed a proclamation declaring the 2009 H1N1 influenza pandemic a National Emergency to facilitate the nations ability to respond to the H1N1 pandemic by enabling if warranted the waiver of certain statutory federal requirements for medical treatment facilities
Drugs approved on the basis of surrogate endpoints
- Reed Smith LLP
- -
- USA
- -
- October 30 2009
FDA is authorized to approve applications based on clinical trials that demonstrate a new drug’s impact on a "surrogate endpoint," or laboratory measure or physical sign used as a substitute for a clinical endpoint
FDA debarment and disqualification processes
- Reed Smith LLP
- -
- USA
- -
- October 30 2009
The GAO issued a report entitled "Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Medical Product Investigators."
FDA guidance documents
- Reed Smith LLP
- -
- USA
- -
- December 4 2009
FDA released a number of final and draft guidance documents in November, including the following
Public hearing on promotion of FDA-regulated medical products using the internet and social media tools
- Reed Smith LLP
- -
- USA
- -
- December 4 2009
The FDA recently held a hearing to help the agency determine how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the internet and newer technologies
Current Search
- Firm Name - Reed Smith LLP
- Workarea - Healthcare
- Author - Paul Sheives