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U.S. FDA
Interoperability in the Pharma Supply Chain
Framework - When asked, most people say that they believe regulations should avoid dictating specific technologies but instead should dictate desired outcomes and let industry figure out the best technologies to achieve them. The concern is usually that technologies mandated in regulations will inevitably grow old and the regulated industry would then be blocked from taking advantage of newer, more innovative technologies. more09.12.2011Bisphenol A: FDA To Decide On Chemical Used In Food Packaging
The U.S. Food and Drug Administration will decide by March 31 whether to ban a chemical used in water bottles, soup cans and other food and drink packaging that may cause harm to developing babies and young children. The industrial chemical bisphenol A, or BPA, has been used for decades to make plastic and epoxy resin used in the production of packaging for food and beverage products. more
Non-compliance is on the Rise
Steady Increase - All who follow industry trends will have noticed an increase in regulatory actions related to non-compliance issues. We can see this in the increased issuance of inspectional observations - or 483s - by the U.S. Food and Drug Administration (U.S. FDA) and by the withdrawal of certificates of suitability (CEP) certifications by the European Directorate for the Quality of Medicines and Healthcare (EDQM). more09.06.2011Next-Generation Instrument Simplifies Sample Preparation
Hamilton Bonaduz is introducing the Microlab 600, the next generation of semi-automated laboratory diluters and dispensers for sample preparation. Based on Hamilton's leading syringe technology, the new Microlab 600 instrument has been designed for ease of use and offers flexibility for more routines and smaller sample volumes. Features more30.05.2011Biofuel Maker Solazyme Shares Rise in Nasdaq Debut
Shares of biofuel maker Solazyme Inc rose 15% in their stock market debut on Friday after the company's IPO raised more than expected. South San Francisco-based Solazyme uses algae to make oil and plans to sell fuel oil, dietary supplements and skin care products. It is the latest of a handful of companies that make fossil fuel alternatives and have sought money successfully from the U.S. capital markets. U.S. more
Social Media and Networking in the Life Science Industry
Social media and social networking are at the forefront for many industries, and the life sciences industry is no different. George Ng, a partner at Gordon & Rees LLP, highlights the many uses and benefits of social media and social networking, as well as the associated risks. more
The EFCG is Pushing Its Agenda Forward During Complex Times
Tony Scott credits Hovione CEO Guy Villax with coining the phrase, "saints and sinners" when referring to the notoriously uneven playing field in the world of API and excipient manufacture at the launch of EFCG during CPhI in Brussels in 2004 . The European Fine Chemicals Group - better known as the EFCG - has become a household name over the last six years when it comes to pushing for better regulation of APIs and excipients. more07.04.2011Top M&A Law Firms At Center Of New Insider Case
A lawyer and a trader were accused by federal prosecutors of running a 17-year conspiracy to trade on corporate merger secrets stolen from three of the nation's most powerful law firms, in one of the largest U.S. insider trading cases on record. more06.04.2011Merck To Acquire Inspire Pharma For $430 Million
Merck & Co said on Tuesday it would acquire eye treatment maker Inspire Pharmaceuticals for about $430 million to expand its ophthalmology business. Inspire's key product is Azasite, a treatment for bacterial conjunctivitis, sometimes referred to as "pink eye." It also receives royalties on sales of Allergan dry-eye drug Restasis. more30.03.2011J&J Recalling More Tylenol From Closed Plant
Johnson & Johnson said it was recalling more than 700,000 bottles or packages of Tylenol and other consumer medicines made at a now-closed plant, the latest in a litany of recalls by the company. J&J's McNeil Consumer Healthcare unit recalled one lot of Tylenol 8 Hour Extended Release Caplets, or 34,056 bottles, from retailers, the company said. more- Legal
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