The European Medicines Agency (EMA) has released recommendations concerning pack design and labelling for non-prescription medicines for a 3-month public consultation period, which will run until 30 June 2011. Such features are important for the safe use of all medicines, but are arguably more crucial for non-prescription medicines — especially when no intervention from a pharmacist is required. For this blog, I thought I’d take a an in-depth look at the recommendations and what pharma manufacturers will be required to provide, if the recommendations are enforced.
Archive for the 'Packaging & Labeling' Category
Barely a month after its ruling in Bruesewitz v. Wyeth, the US Supreme Court has begun to hear arguments in another case with big ramifications for drugmakers. The current case raises questions about generic-drug companies’ responsibilities and whether federal law pre-empts state regulations, among other issues. Read more »
Have you ever been confused by instructions on a medicine bottle or packet of pills? When it says “avoid alcoholic drinks”, does it mean avoid completely or just cut down? And how exactly should the word “drowsiness” be interpreted? Sleepy? A bit tired? Read more »
At a press conference in the waning days of 2010, Senator Amy Klobuchar (D-MN) raised an alarm about what she called an “unprecedented” drug shortage. Citing a scarcity of treatments for chemotherapy, she called for greater collaboration between industry and FDA to ensure that Americans have access to the medicines they need. But shortages also can affect drugs that are used for purposes other than healing. Read more »
Big Pharma companies with weak pipelines likely envy the makers of generic drugs, whose profits stand to increase as innovators’ drugs lose patent protection. But business for generic-drug manufacturers is not necessarily simple. In fact, a lawsuit to be heard by the US Supreme Court shows that these companies may face significant risks, even if they play by the rules. Read more »
Industry executives revealed their biggest worries for global supply-chain management in a report by PricewaterhouseCoopers and the analyst firm Axendia that focused on major areas of concern in the pharmaceutical supply chain. The report, titled Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences: Business Imperative, Regulatory Necessity, surveyed 112 executives from the pharmaceutical, medical device, and biotechnology sectors. Read more »
It’s been four years since the International Conference on Harmonization adopted ICH Q3B(R2), which harmonizes the content and qualification of impurities in drug substances, including extractables and leachables (E&L) produced by the interaction of a drug substance and its container-closure system. And yet, there still seem to be a huge amount of questions surrounding these degradation byproducts, stability testing, thresholds, and reporting requirements.
Italians are known for their passions. They are passionate about their food, their wine, their art, their design, and in Bologna, they are passionate about their packaging industry. And well they should be. In a time of economic crisis, Italy’s packing industry seems extremely healthy, based on the statistics offered last week by Dr. Guido Corbella, at the Pharmintech exhibition.
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Spring is in the air, and it’s time for a trip to the Javits Center for the annual INTERPHEX conference and exhibition. The editors of Pharmaceutical Technology and BioPharm International have arranged a series of interviews during the conference. We’ll be talking to pharmaceutical professionals, information-technology experts, and regulators about current challenges in manufacturing and about what the future might bring. Read more »
Pharmaceutical supply-chain managers have yet another item to step up their control of: tractor-trailers. A critical part of the delivery of supply, these large trucks have been used by many pharmaceutical companies for years to transport raw materials, ingredients, and final drug products. Cargo theft has always been a concern, but that concern is now growing. Read more »