FDA, regulatory and legalColumns examine the legal and regulatory developments, guidances, and rulings that affect the packaging of drugs, biologics, and medical devices.HCPC ‘s Sept. 15 Showcase to focus on healthcare reform’s impact on pharmaceutical packagingBruce Cohen to deliver keynote address at one-day industry event at Honeywell’s corporate headquarters in Morristown, NJ.... FDA, regulatory and legal | August 25, 2010 Label issues present varied challengesDistribution environment, regulatory and compliance issues, and marketing messages are among the key concerns for manufacturers.... Labels | August 24, 2010 The August 2010 FDA Patient Safety News is now available...You can find more information about FDA Patient Safety News, and watch or download the video program on our web site . Stories in the August 2010 edition include:... FDA, regulatory and legal | August 12, 2010 Novacare LLC Products: Recall - Undeclared Drug IngredientProducts sold under the following names: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45, and Zilex (with Golden Spear)... FDA, regulatory and legal | August 12, 2010 Revivexxx Extra Strength: Recall - Undeclared Drug IngredientAUDIENCE: Consumer ISSUE: FDA lab analysis of Revivexxx Extra Strength was found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Revivexxx Extra Strength an unapproved drug. This poses a threat... FDA, regulatory and legal | August 9, 2010 Solo Slim, Solo Slim Extra Strength: Recall - Undeclared Drug IngredientAUDIENCE: Cardiology, Consumer ISSUE: FDA lab analysis of Solo Slim was found to contain the undeclared drug ingredient Didesmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. This poses a threat to consumers because... FDA, regulatory and legal | August 9, 2010 June 2010 Drug Safety Labeling Changes: 28 Medical Product Labels with changesThe MedWatch June 2010 Drug Safety Labeling Changes posting includes 28 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.... FDA, regulatory and legal | August 4, 2010 FDA medication error draft guidance to come by Sept. 30Packaging, such as container/carton labels, will be considered by the agency in an attempt to reduce errors.... FDA, regulatory and legal | July 30, 2010 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 * 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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