FDA, regulatory and legalColumns examine the legal and regulatory developments, guidances, and rulings that affect the packaging of drugs, biologics, and medical devices.FDA Data Standards Update - SPL Terminology Update - UNIIsThe FDA Data Standards Council’s website was updated Wednesday, January 20, 2010, to include updated terminology:... Press Releases | February 1, 2010 Wanted: Innovative packaging for biotechnology productsCiting Research and Markets’ report, “The Future of the Pharmaceutical Packaging Industry—Emerging Economies Poised to Capitalize on Increasing Demand,” Pharmacychoice.com reports that the global pharmaceutical packaging market will show a 6.9% compound annual growth rate to reach a value of... Pharmaceuticals and biologics | January 29, 2010 FDA flexes its muscleSeveral months ago, Packaging World/Healthcare Packaging legal columnist Eric Greenberg pointed out that the U.S. Food & Drug Administration would increase its activity in the new administration under Dr. Margaret Hamburg.... FDA, regulatory and legal | January 25, 2010 Crestor closer to expanded useFDA advisory committee voted 12 to 4 (one abstaining) to broaden use of cholesterol-lowering Crestor to people with normal cholesterol and no history of heart disease.... FDA, regulatory and legal | December 21, 2009 FDA Expands Presence Outside U.S. with Opening of Mexico City PostAs part of its continuing effort to buttress food and medical product safety in this country by working with its regulatory partners overseas, the U.S. Food and Drug Administration today announced the opening of its Mexico City post.... FDA, regulatory and legal | December 15, 2009 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect PackagingBayer Consumer Care and FDA notified Consumers of a recall of a single product lot of the combination package of Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels.... FDA, regulatory and legal | December 9, 2009 Compliance Checklist for FDA-regulated Companies Now Available from Dickson CompanyWorldwide food and drug companies selling to the U.S. market can now obtain a free FDA 21 CFR Part 11 Checklist to ensure full regulatory compliance of their environmental monitoring practices.... Validation, compliance and documentation | December 7, 2009 Steris System 1 Processor: FDA Notice and RecommendationsFDA notified healthcare facility administrators and infection control healthcare professionals of important information regarding the regulatory status of the STERIS System 1 Processor (SS1) used in surgical and endoscopy suites for reprocessing, i.e., sterilizing or disinfecting, medical devices.... FDA, regulatory and legal | December 7, 2009 Labeling revisions take aim against medication errorsThe U.S. Pharmacopeia proposes revisions to ferrules and cap overseal labeling.... FDA, regulatory and legal | December 7, 2009 FDA Data Standards Update - SPL Terminology Update - UNIIsThe FDA Data Standards Council’s website was updated Tuesday, November 24, 2009, to include updated terminology.... FDA, regulatory and legal | December 1, 2009 FDA Data Standards Update - SPL Terminology Update - UNIIs - Over 12,000 UNIIs Now AvailableThe FDA Data Standards Council’s website was updated Saturday, November 21, 2009, to include updated terminology.... FDA, regulatory and legal | November 30, 2009 FDA Data Standards Update - SPL Terminology UpdateThe FDA Data Standards Council’s website was updated Wednesday, November 18, 2009, to include updated terminology:... FDA, regulatory and legal | November 30, 2009 Labels critical for pharmaceuticalsOften overlooked during product/package development, labels communicate with consumers, address regulatory matters.... Labels | November 25, 2009 Countering Internet drug counterfeitingThe future of Internet drug enforcement comes into focus with an international anti-counterfeiting operation and multifaceted FDA efforts.... FDA, regulatory and legal | November 24, 2009 FDA addresses online drug claim offenders in what could be a glimpse into the future of enforcement actionsFDA addresses online drug claim offenders in what could be a glimpse into the future of enforcement actions.... FDA, regulatory and legal | November 24, 2009 Centurion Medical Products Premie Pack and Meconium Pack Recall*Centurion Medical Products and FDA notified healthcare professionals about a Class I recall of Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115. The pediatric tracheal tubes used in these kits were manufactured with an... FDA, regulatory and legal | November 17, 2009 Bodybuilding.com Dietary Supplements-Sold on Internet: recalled due to undeclared steroids in products with risk of acute liver injury*Bodybuilding.com and FDA notified healthcare professionals and patients of a nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the Company's website, www.bodybuilding.com.... FDA, regulatory and legal | November 17, 2009 FDA MedWatch - November 2009 FDA Patient Safety News now available*FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals.... FDA, regulatory and legal | November 17, 2009 FDA Commissioner Margaret Hamburg to Deliver Keynote Address at DIA 46th Annual Meeting*Dr. Margaret Hamburg, Commissioner of the US Food and Drug Administration (FDA), will deliver the opening keynote address to more than 8,000 professionals from the biopharmaceutical and related sectors at the Drug Information Association (DIA) 46th Annual Meeting.... FDA, regulatory and legal | November 17, 2009 Cancer chemo patients improve quality of life; complex sugar drug DAVANAT proven in four FDA trials*In four FDA trials, 97 cancer patients were dosed with a combination of chemotherapy and DAVANAT. During the trials, patients taking DAVANAT experienced significantly fewer serious side effects of chemotherapy including mucositis, gastrointestinal problems, loss of hair, nausea and vomiting... Clinical Trials | November 17, 2009 * 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. |
|
Home | Subscribe | Advertise | Contact us | Site Map | Privacy | © Copyright 2010 Summit Publishing. |
Please visit these related packaging, design and automation Web sites:Global Package Gallery – Gallery of package design images featuring 7,000+ high-resolution images Shelf Impact! – Strategies for successful package design and marketing Packworld.com – News and information on packaging machinery, packaging materials, and packaging suppliers Greener Package – Knowledge exchange for sustainable packaging On The Edge – An independent blog on packaging automation and leadership featuring Keith Campbell PackagingAutomation.net – Packaging machinery automation trends Automation World – Intelligence on manufacturing automation trends |
