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Tobacco Panel to Discuss Dissolvable Products

[ Price : $8.95]

Federal Register Notice: FDAs Tobacco Products Scientific Advisory Committee will meet 11/2 to discuss the use of dissolvable toba...

OncoGenex Amends SPA with FDA to Expand Prostate Cancer Trial

[ Price : $8.95]

OncoGenex completes an amendment of its Special Protocol Assessment with FDA to expand the inclusion criteria for its SATURN clini...

Amneal Generic Antiepileptic Out

[ Price : $8.95]

Amneal Pharmaceuticals releases a 400 mg and 600 mg first-to-market generic antiepileptic felbamate.

FDA PDUFA 5 Reauthorization Public Meeting

[ Price : $8.95]

FDA schedules a 10/24 public meeting to hear comment on proposed recommendations for the PDUFA 5 reauthorization.

Medtronic Pedicle Screw Cleared for Adolescent Scoliosis

[ Price : $8.95]

FDA clears a Medtronic 510(k) for the company's TSRH Spinal System pedicle screw and its use in treating adolescent idiopathic sco...

Firm's 30-year Battle with CDRH, Now Hits Classification Snag

[ Price : $8.95]

Electromedical Products International CEO Tracey Kirsch says her negative experiences with FDA regulations and staff over 30 years...

Conference on Pharmaceutical Manufacturing Life-Cycles

[ Price : $8.95]

Federal Register Notice: FDA co-sponsors a public conference 10/4-6 to teach the ICH principles of effective life-cycle implementa...

Genzyme Supply Issues Again with Cerezyme

[ Price : $8.95]

Genzyme says it is again having supply issues with its Gaucher's Disease drug Cerezyme.

Industry, Patients on Opposite Sides at 510(k) Change Meeting

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A public meeting on IoM recommendations for changes to FDAs 510(k) program draws predictable comments, with industry critical of t...

Wholesalers, Pharmacists Lead Counterfeit/Diversion Cases

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A preliminary report finds drug wholesalers represented the greatest percentage (27%) of suspects followed by pharmacists (13%) in...