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FDA OKs Novartis sNADA for Swine Diseases

09/08/2010

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Novartis Animal Health supplemen...

Special Controls Guidance on Coronary Angioplasty Catheters

09/08/2010

Federal Register Notice: FDA is making available a guidance, Class II Special Controls Guidance Document for Certain Percutaneous ...

FDA Codifies Ophthalmic Solution for Dogs

09/08/2010

Federal Register Final rule: FDA is amending the animal drug regulations to codify the conditions of use of an approved NADA for g...

FDA Reclassifies Coronary Angioplasty Catheters

09/08/2010

Federal Register Final rule: FDA is reclassifying the device type, standard percutaneous transluminal coronary angioplasty (PTCA) ...

Public Workshop on Pediatric Neuroprostheses

08/20/2010

Federal Register Notice: FDA will hold a public workshop 9/13 entitled ASK (Assess Specific Kinds of CHILDREN Challenges for Neuro...

FDA Withdraws 27 NDAs, 58 ANDAs

07/21/2010

Federal Register Notice: FDA is withdrawing approval of 27 NDAs and 58 ANDAs from multiple applicants. The holders of the applicat...

ICH Guidance on Bacterial Endotoxins

07/19/2010

Federal Register Notice: FDA is making available a draft guidance, Q4B Evaluation and Recommendation of Pharmacopeial Texts for Us...

List of PMAs Published

07/02/2010

Federal Register Notice: FDA is publishing a list of PMAs that have been approved to inform the public of the availability of safe...

FDA OKs Norbrook Labs Revised Penicillin Injectable

06/21/2010

Federal Register Notice: FDA has approved a Norbrook Laboratories supplemental NADA for use of Norocillin (penicillin G procaine) ...

FDA Issues 7 Emergency Permits for H1N1 Kits

06/21/2010

Federal Register Notice: FDA has issued seven Emergency Use Authorizations, two of which were amended after initial issuance, for ...