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Clinical Trial SOPs: Ensure Your Procedures are Compliant and Followed Correctly (Thursday, September 09 2010 at 2:00 PM ET) A Drug Recall Case Study: Lessons Learned from a Widespread Drug Recall at a Major Pharmaceutical Company (Tuesday, September 14 2010 at 2:00 PM ET) False Claims Act Liability for Pharmaceutical and Medical Device Companies: How Will Recent Changes Affect You? (Tuesday, September 21 2010 at 2:00 PM ET) How Health Care Reform and Other New Legislation Will Affect the Regulation of Advertising and Promotion (Tuesday, September 28 2010 at 2:00 PM ET) FDA's Changes to the 510(k) Process: Are You Prepared? (Thursday, September 30 2010 at 2:00 PM ET) Device Complaint Handling: Implications for CAPA, Reporting, Recalls and More (Tuesday, October 05 2010 at 2:00 PM ET) Online Products
FDA Advertising and Promotion Manual Online Edition
FDA Enforcement Manual Online Edition Guide to Good Clinical Practice Online Edition Guide to Medical Device Regulation Online Edition |
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| The Food and Drug Regulation Library provides complete, reliable information on: FDA regulation, FDA compliance and enforcement, FDA and Federal Trade Commission (FTC) advertising policies, how and why FDA conducts inspections, responding to 483s and warning letters, medical device regulation, food labeling, clinical trials of new drugs, devices, and biologics dietary supplements, pharmaceutical, food and drug law, genetically modified food labeling, nutrition labeling, nutrient content and health claims, U.S. Department of Agriculture labeling rules, country-of-origin labeling, Food and Drug Administration (FDA), FDA Modernization Act (FDAMA), Prescription Drug User Fee Act (PDUFA), biotechnology regulations, in-vitro diagnostic device (IVD) regulation, Federal Food Drug and Cosmetic Act, and good manufacturing practices (GMPs). |
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| Health Care Reform: What FDA-Regulated Industries Need to Know |
 Learn new provisions affecting Clinical Trial Costs, Medical Device Excise Tax, Fraud Prosecutions, and the Sunshine Provision. |
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