The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA today issued draft guidance to manufacturers of over-the-counter (OTC) acetaminophen products, providing alternative language to the liver warning section of the product’s labeling. In certain instances, FDA now will allow manufacturers to state the maximum daily dosage as 4,000 mg in a 24-hour period for the liver warning. This language can be used instead of specifying the maximum number of tablets or dosage units for the product, as has been required. Please find additional information at: http://www.fda.gov/Drugs/DrugSafety/ucm310469.htm Draft Guidance document: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM310477.pdf Draft Guidance for Over-the-Counter Products that Contain Acetaminophen
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM. Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
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