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FDA OKs Akorns Generic Ciloxan

[ Price : $8.95]

FDA approves an Akorn ANDA for a generic copy of Alcons Ciloxan.

FDA Accepts sNDA for Mercks Identress

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FDA accepts a Merck supplemental NDA for Isentress (raltegravir) tablets, seeking approval for the drugs combination use with othe...

Advisors Want Asthma Drug Restrictions

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FDA advisors say risks associated with asthma drugs Serevent and Foradil outweigh benefits for most patients.

Its Official, Daschle Nominated to Head HHS

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President-elect Barack Obama officially nominates former senator Tom Daschle (D-SD) as Health and Human Services secretary.

FDA Accepts for Review a Duramed BLA for Vaccine

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FDA accepts for review a Duramed Pharmaceuticals BLA for its Adenovirus Types 4 and 7 Live Oral Vaccine, a vaccine developed under...

Should FDA Require Pre-market ICD Trials?

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CDRH director Daniel Schultz responds to critics who say a new ICD lead should be subject to clinical trials before marketing by s...

FDA Issues Draft 510(k) Sterility Info Guidance

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FDA issues a draft guidance updating and clarifying procedures for reviewing 510(k) submissions for devices labeled as sterile.

Proposed Massachusetts Marketing Regs Out

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The Massachusetts Department of Public Health releases for comment proposed regulations implementing a marketing code of conduct f...

More Data Needed for Remoxy NDA

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FDA says Pain Therapeutics must provide more non-clinical data to support approval of its NDA for Remoxy.

New PhRMA Code Doesnt Go Far Enough: Critics

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Capitol Hill lawmakers and advocacy groups criticize PhRMAs revised marketing code on DTC ads, saying that it doesnt go far enough...