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Guidance on Drugs to Treat Intra-Abdominal Infections

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance, Complicated Intra-Abdominal Infections: Developing Drugs for Treatment.

Guidance on Developing Drugs for Chronic Bronchitis in Patients with COPD

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance, Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obs...

Workshop Slated on Peripheral Neuropathy

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Federal Register Notice: CDER plans a public workshop 2/11-12/13 to discuss clinical development of disease-modifying agents for t...

Coyote Pharma Plans IND Filing for ALS/Alzheimers Treatment

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Coyote Pharmaceuticals plans to file an IND with FDA and begin a clinical program in 2013 for its CNS-102 to treat Amyotrophic Lat...

PhRMA Principles on Interacting with Patient Groups

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PhRMA adopts new principles to guide interactions between pharmaceutical companies and patient organizations in the wake of the ne...

Draft Guidance on Drugs for Treating Intra-Abdominal Infection

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FDA releases a draft guidance for industry to assist sponsors in developing drugs for treating complicated intra-abdominal infecti...

FDA Postpones Gastrointestinal Panel Meeting

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Federal Register Notice: Due to scheduling issues, FDA postpones a 10/15 Gastrointestinal Drugs Advisory Committee slated to discu...

PhRMA Brief Seeks High Court Patent Settlement Review

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PhRMA files an amicus brief asking the Supreme Court to resolve whether brand and generic companies can reach monetary settlements...

FDA Campaign Against Rogue Pharmacy Sites

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FDA launches a national campaign to raise public awareness about fraudulent Internet pharmacies.

Comments Sought on Environmental Impact Info

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Federal Register Notice: FDA seeks comments on a collection of information on environmental impact considerations.