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FDA Releases Product-Specific BE Recommendations

06/20/2013

Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE)recommenda...

Guidance on ANDA Stability Testing

06/20/2013

FDA Amends Orphan Drug Regs

06/12/2013

Federal Register Final rule: FDA is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Or...

FDA Proposes Serious Pathogen List

06/12/2013

FDA Proposes Classifying Stair-Climbing Wheelchairs into Class 2

06/12/2013

Federal Register Proposed order: FDA is issuing a proposed administrative order to reclassify stair-climbing wheelchairs, a Class ...

Comments Sought on Info on BLA Licensing

06/12/2013

Federal Register Notice: FDA is seeking public comment on the collection of information on to general licensing provisions for BLA...

Comments Sought on IND Safety Reporting Info

06/12/2013

Federal Register Notice: FDA is seeking comments on the information collection resulting from IND safety reporting requirements an...

FDA Publishes Approved PMA List

06/12/2013

Federal Register Notice: FDA is publishing a list of PMAs that have been approved and is informing the public of the availability ...

Comments Sought on Orphan Drug Procedures Info

06/12/2013

Federal Register Notice: FDA seeks comment on the proposed collection of information on the procedures by which sponsors of orphan...

Comments Sought on Electronic Product Requirements

06/12/2013