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Faster Information from FDA Means Improved Drug Safety for Patients. Guidance for Industry, Warning Letters, Postmarket Surveillance Programs, Rules and Regulations. Medication Guides, Drug Shortages, Drug Safety Communications and Other Safety Announcements. FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women. New drug treats a certain type of advanced ovarian cancer. Warnings on repeated, lengthy use of anesthetics, sedatives.
FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. FDA grants accelerated approval to new treatment for advanced ovarian cancer. About the Center for Drug Evaluation and Research. Risk of mental health side effects lower than suspected. Research by FDA Staff to Evaluate and Enhance the Safety of Drug Products. New ointment approved to treat skin condition eczema. Conducting Clinical Trials, Types of Drug Applications, Forms and Submissions Requirements, Labeling Initiatives, Drug and Biologic Approval Reports.
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