FDA, regulatory and legalColumns examine the legal and regulatory developments, guidances, and rulings that affect the packaging of drugs, biologics, and medical devices.FTC gives Nestlé a ‘time out’ for functional food claims aimed at kidsJust six weeks after Kellogg’s Rice Krispies took a hit for claiming to help boost kids’ immune systems, Nestlé has been called out for deceptive messaging.... FDA, regulatory and legal | July 27, 2010 Plant monitoring system• viewLinc 3.5 is fully validatable for FDA-regulated, GxP-compliant environments, providing continuous records, 24/7 alarming, and automated reporting • easily deployable for monitoring temperature, RH, CO2, differential pressure, and more • for larger pharmaceutical packaging plants and medical product packagers,... FDA, regulatory and legal | July 26, 2010 Arava (leflunomide): Boxed Warning - Risk of Severe Liver InjuryAUDIENCE: Rheumatology, Family Practice... Press Releases | July 16, 2010 Uptick forecasted in healthcare M&A activityStudy reports findings based on interviews with more than 75 U.S. healthcare investors covering various life science sectors.... FDA, regulatory and legal | July 16, 2010 Genzyme, Hospira reach expanded fill and finish manufacturing dealFollows consent decree with the FDA that said Genzyme had to move fill and finish operations out of its Allston, MA facility.... FDA, regulatory and legal | July 12, 2010 Tamiflu: Counterfeit Product Sold on InternetFraudulent product is dangerous to patients allergic to penicillin.... FDA, regulatory and legal | July 7, 2010 Avandia controversy escalatesOne Senator and one member of Congress are calling on the FDA to pull from the market the diabetes drug Avandia because of safety concerns. It’s the latest flare-up of a firestorm of controversy--and a window into several important issues.... FDA, regulatory and legal | July 2, 2010 May 2010 Drug Safety Labeling Changes23 Medical Product Labels with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions.... FDA, regulatory and legal | June 28, 2010 Vitamin D Supplement Products: Medication Use ErrorSome liquid Vitamin D supplements sold with droppers that could allow harmful amounts of Vitamin D to be dispensed.... FDA, regulatory and legal | June 28, 2010 FDA Takes Action Against California Soy-Product Manufacturer LifesoyProducts made under conditions that violated federal law.... FDA, regulatory and legal | June 18, 2010 Cutting through confusing health and wellness claimsKnowing the differences between nutraceuticals, dietary supplements, and medical foods before packaging and labeling is an important lesson learned.... Functional foods and beverages | June 16, 2010 FDA Warns Consumers to Avoid Vita Breath Dietary SupplementProducts may contain high levels of lead.... FDA, regulatory and legal | June 7, 2010 FTC targets Snap, Crackle and Pop for health claims on Rice KrispiesPackage claims cereal “now helps support your child’s immunity.”... FDA, regulatory and legal | June 7, 2010 FDA Announces Collaboration with Drugs.comThe U.S. Food and Drug Administration announced today that it will collaborate with the Web site Drugs.com to expand access to the FDA’s consumer health information.... FDA, regulatory and legal | June 2, 2010 WSJ blog reports FDA weighing penalties against J&JPlant violations, weak responses to consumer complaints, and buying suspect packages off store shelves concern the FDA.... FDA, regulatory and legal | June 1, 2010 Orlistat (marketed as Alli and Xenical): Labeling ChangeFDA notified healthcare professionals and patients that it has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication.... FDA, regulatory and legal | June 1, 2010 Labeling a focus of FDA’s new Medical Device Home Use InitiativeRecognizing the aging U.S. population and shifts toward shorter hospital stays, the agency looks to protect patients using medical devices at home.... FDA, regulatory and legal | May 27, 2010 FDA says no criminal charges from medical device accusationsThe U.S. Food & Drug Administration says there won't be criminal charges against FDA officials for abuses in review of medical devices, according to the Wall Street Journal.... FDA, regulatory and legal | April 26, 2010 New FDA regs may prompt cigarette package labeling changesAgency addresses marketing of tobacco products to minors, announces ‘FDA-TRACK’ program for transparency and accountability.... FDA, regulatory and legal | April 22, 2010 How to avoid and respond to FDA 483 lettersWith FDA 483 letters expected to increase this year, reflecting the agency’s recent staff expansion, this report advises how to avoid and respond to public FDA criticisms—Form 483 Letters—for temperature, humidity and other controlled environments.... FDA, regulatory and legal | April 16, 2010 * indicates a sponsored article that was submitted directly to this Web site by the supplier, and was not handled by the Healthcare Packaging editorial staff. Healthcare Packaging may share your contact information with our sponsors, as detailed in our Privacy Policy. Healthcare Packaging will not share your information with a sponsor whose content you have not reviewed. |
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