FDA grants accelerated approval to new treatment for 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. Risk of mental health side effects lower than suspected.
Guidance for Industry, Warning Letters, Postmarket Surveillance Programs, Rules and Regulations. New ointment approved to treat skin condition eczema. New drug treats a certain type of advanced ovarian cancer. Medication Guides, Drug Shortages, Drug Safety Communications and Other Safety Announcements. Research by FDA Staff to Evaluate and Enhance the Safety of Drug Products. FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women. Conducting Clinical Trials, Types of Drug Applications, Forms and Submissions Requirements, Labeling Initiatives, Drug and Biologic Approval Reports.
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