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Three Lots of Reagents Recalled

[ Price : $8.95]

CBER says Ortho Clinical Diagnostics is recalling three lots of its Blood Grouping Reagent Anti-Lea BioClone 2.0.

Onset Therapeutics NDA for Genital Warts

[ Price : $8.95]

Onset Therapeutics submits an NDA for a product indicated for topically treating external genital warts.

FDA Urged to Test Food Animals for MRSA

[ Price : $8.95]

Keep Antibiotics Working says Congress should order FDA to determine whether U.S. cattle, swine, and poultry harbor MRSA.

Ipsen BLA for Cervical Dystonia

[ Price : $8.95]

Ipsen files a BLA for Dysport (botulinum neurotoxin type A complex) for injection, indicated for treating patients with cervical d...

Researchers Want FDA to Ban OTC Pediatric Cold Meds

[ Price : $8.95]

Researchers urge FDA to begin legal proceedings to force the market removal of pediatric cough and cold medications.

Vodra Skeptical of FDA Amendments Effects

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Citing lack of FDA resources, Arnold & Porter senior counsel Bill Vodra expresses skepticism on the practical effect of new author...

FDA OKs Belcher Pharma ANADA

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Federal Register Final rule: FDA approves Belcher Pharmaceuticals ANADA for veterinary use of carprofen caplets in dogs.

FDA OKs Elanco Animal sNADA

[ Price : $8.95]

Federal Register Final rule: FDA approves an Elanco Animal Health supplemental NADA to revise monensin concentration of cattle fee...

FDA Approves Elanco sNADA for Cattle, Goat Feed

[ Price : $8.95]

Federal Register Final rule: FDA approves Elanco Animal Healths sNADA to remove a 30-day expiration labeling for monensin goat and...

FDA OKs Caracos Generic Norvasc

[ Price : $8.95]

FDA approves a Caraco Pharmaceutical Laboratories ANDA for a generic copy of Pfizers Norvasc.