Review Period Set for Perjeta
05/19/2014
Federal Register Notice: FDA has determined the regulatory review period for Genentech’s Perjeta (pertuzumab) is 3,925 days ...
Review Period Set for Zioptan
05/19/2014
FDA Reassesses Minor Use Animals
05/19/2014
Federal Register Notice: FDA is announcing its periodic reassessment for defining the small numbers of animals for minor use in ma...
Info on Animal Drug User Fees Sent to OMB
05/16/2014
Info on Safety Communication Sent to OMB
05/16/2014
Intravascular Administration Set into Class 2
05/16/2014
Federal Register Final order: FDA is classifying the intravascular administration set, automated air removal system into Class 2 (...
Colon Imaging System into Class 2
05/16/2014
Federal Register Final order: FDA is classifying the colon capsule imaging system into Class 2 (special controls). The special con...
Info on ICH Benefit/Risk Report Sent to OMB
05/09/2014
Info on Tobacco Product Violations Sent to OMB
05/09/2014
Federal Register Notice: FDA’s proposed collection of information, “Potential Tobacco Product Violations Reporting For...
Guidance on SLA Laser Products
05/05/2014
Federal Register Notice: FDA is making available a draft guidance entitled Surveying, Leveling, or Alignment Laser Products. The q...
