Author Archive

FDA Assesses Goals due to Hurricane Sandy

FDA has pushed back goals in relation to the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) as a result of the closing of agency offices during Hurricane Sandy. FDA says it will assess the goals that were due October 31 and extend them as needed. The extensions will be no more than the number of business days the agency was closed.

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Eli Lilly Chairman Stresses the Importance of Biopharmaceutical Innovation on the Economy

The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy. Eli Lilly Chairman, President and CEO John C. Lechleiter recently weighed in on the issue with respect to the pharmaceutical industry in offering his perspective on the importance of including data exclusivity provisions for biologics as found in US law for the Trans-Pacific Partnership (TPP), a regional free trade pact in Asia under negotiation.

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Is FDA putting your company’s confidential data at risk?

An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question.  Earlier this year, the New York Times reported that FDA had tracked employee emails in its investigation into the possible leak of agency information by FDA scientists who complained about the agency’s medical device review process. These scientists raised concerns about radiation danger levels.

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USP Updates Heparin Sodium Monograph

In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin. In response to the 2008 heparin situation, the United States Pharmacopeia Convention (USP) has revised the quality standards for heparin. Anita Szajek, PhD, and Tina Morris of USP highlight USP’s revisions to the heparin sodium monograph in the September 2012 issue of PharmTech.

Borders on Intellectual Property

An upcoming report on India’s pharmaceutical industry in PharmTech (check out the October 2012 issue) discusses India’s strict patent policies and got me thinking about the rights of intellectual property versus patients’ rights to needed medicines. PharmTech’s Asia correspondent, Jane Wan, reports that India has set a high bar for patent approval that Western drug manufacturers are finding frustrating.

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PhRMA Defends US Innovation

PhRMA Senior Vice-President Matthew Bennett released a statement today on the state of the biopharmaceutical industry, in response to an analysis in the British Medical Journal. Bennett states that while the US may be lagging behind in spurring innovation programs, he believes the passage of the Prescription Drug User Fee Act (PDUFA) will improve the situation.

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Cooperation in Global Regulation Sees Benefits

The European Medicines Agency announced on July 30, 2012, that its efforts to increase interaction and cooperation with regulatory authorities in Japan have paid off. In 2007, confidentiality agreements between the EU and Japan were established for a five-year period to allow for an exchange of information to enhance regulatory and scientific processes. According to EMA, the areas of orphan drugs, pediatrics, advanced therapies, pharmacogenomics, and nanomedicines have especially benefited from the collaboration. Read more »

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