PDUFA V: Risk – Benefit Emphasis New

What is new about PDUFA V?   Congress, the media, and the public have a history of boiling down the issue to whether drugs are safe or not safe. what does ivermectin treat in cattle   In reality the issue is benefit versus risk. ivermectin is effective    In addition,...

FDA Resource for Approved Drug Information

Ever wanted to know the ins and outs of almost every drug approved by the Food and Drug Administration since 1939? قوانين البوكر By using the Drugs@FDA database, you can search for information about FDA-approved brand name and generic drugs and therapeutic biological...

Drug Safety: Tip of the Iceberg

The 10 drugs with the largest numbers of reports sent directly to the FDA by healthcare practitioners and consumers in 2011 in order of frequency are Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim.  It is interesting...

Potential Academic Contributions to Drug Development

Dr. Janet Woodcock (CDER, FDA) stated that for every 10 drugs that enter Phase I clinical trials, only 1 drug is approved. using ivermectin for heartworm prevention   The cost of bringing an innovative drug to market often requires a decade and a billion dollars of...

Drug Safety: IOM Pharmacovigilance Report

An Institute of Medicine (IOM) committee report, recommends that the FDA take proactive steps to continue monitoring drug safety after initial approval and throughout the market lifecycle.   Post-market evidence is far greater than what the FDA has when deciding upon...

Nonclinical Toxicology: FDA Guidance Agenda for 2012

The Federal Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a list of planned draft and final guidance documents for release in 2012. لعبة الكازينو   There are about 50 such guidances planned.  Below are a few select highlights...