Archive for the 'Packaging & Labeling' Category

Using Drugs Right

Angie Drakulich PharmTech editorI just finished writing an article on over-the-counter (OTC) drugs and how their safety and market approvals are managed (look for it in the May issue of PharmTech). As a consumer, something stood out in my research. Read more »

Companies Claiming MRSA Prevention are in Hot Water with FDA

This blog post was written  by Christina I. Ortiz

You might want to rethink buying that bulk-sized hand sanitizer if you’re trying to protect you and your family from Methicillin Resistant Staphylococcus Aureus bacteria (MRSA) and other diseases. FDA is cracking down on over-the-counter (OTC) drug companies that are claiming their products prevent infection from MRSA.  The agency has sent letters to firms Tec Laboratories, JD Nelson and Associates, Dr. G.H. Tichenor Antiseptic Co., and Oh So Clean, Inc. (who also does business as “CleanWell Company”), among others. Read more »

EMA Issues Packaging And Labelling Recommendations

Stephanie Sutton Pharm Tech EuropeThe 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.

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How Accountable Are Makers of Generic Drugs?

Erik Greb PharmTech editorBarely 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 »

Is Pharma’s Language Too Confusing?

Stephanie Sutton Pharm Tech EuropeHave 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 »

The Executioner’s Drug

Erik Greb PharmTech editorAt 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 »

Echoes of Avandia

Erik Greb PharmTech editorBig 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 »

New Report Addresses Pharma Execs’ Top Supply-Chain Concerns

Alexis Brekke Pellek PharmTech editorIndustry 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 »

Requirements for Extractables & Leachables Can be Confusing, to Say the Least

Angie Drakulich PharmTech editorIt’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.

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Passionate about Packaging

Michelle Hoffman PharmTech editorItalians 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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