Small Business Guide on Tobacco Regulations
03/28/2012
Panel to Discuss Weight Loss Devices
03/28/2012
Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will mee...
Correction Made on MUMS Drug Designation
03/28/2012
Federal Register Correction: In Title 21 of the Code of Federal Regulations, Parts 500 to 599, revised as of 4/1/11, on page 96, i...
Comments Sought on Investigator Financial Disclosure
03/28/2012
Federal Register Notice: FDA is seeking public comment on an information collection on financial disclosure by clinical investigat...
Guidance on BE Recommendations for Iron Sucrose
03/28/2012
Guidance on Benefit-Risk Determinations in Device Approval
03/28/2012
Federal Register Notice: FDA is making available a guidance document, Factors to Consider When Making Benefit-Risk Determinations ...
Revised Guidance Out on Drug Safety Info
03/09/2012
Guidance on Classifying Postmarket Drug Safety
03/09/2012
Federal Register Notice: FDA is making available a draft guidance, Classifying Significant Postmarket Drug Safety Issues. It descr...
Correction Made in Swine Feed Info
03/09/2012
Federal Register Correction: In 21 CFR, Parts 500 to 599, revised as of 4/1/11, on page 490, in Sec. 558.500, (e)(1)(i) FDA reinst...
Norovirus Reagents into Class 2
03/09/2012
Federal Register Final rule: FDA is classifying norovirus serological reagents into Class 2 (special controls) with a guidance doc...
