Tag Archives: FDA

If Biotech Builds…Will Financers Come?

Angie Drakulich from PharmaTech Talk writes: In many countries, it’s easy to get the health minister to understand the value of introducing a vaccine and related healthcare training and therapies to his or her population. It’s another thing to get the finance minister to buy into the effort. But healthcare education and training have made and continue to make great inroads into this area. Angie is part of our BIO Official Blog Program. Keep an Read More >

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BIO Official Bloggers Program: Focus on Biosimilars

Andrew Williams wrote a second part to his original blog entry on 2011 BIO International Convention preview… This time his focus is on Biosimilars: For BIO attendees interested in learning more about the relatively new pathway for FDA approval of biosimilars, also known as follow-on biologics, there are several sessions devoted to the intricacies of the new law, or how the new legislation is impacting the BIO community.  The biosimilar framework was introduced last year Read More >

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FDA: A Cornerstone of America’s Economic Future

Nancy Myers

By Nancy Bradish Myers, JD, President, Alliance for a Stronger FDA For close to 20 years, we have been told that FDA oversees products that represent 25 percent of all consumer spending. This has always been an impressive statistic and often awakened Capitol Hill to the realization that FDA matters in important and unexpected ways. But is that all there is to FDA’s role in the U.S. economy? Fortunately it isn’t. FDA is a regulatory Read More >

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U.S. Inter-Agency Group takes on Counterfeit Pharmaceuticals

The Office of the Intellectual Property Enforcement Coordinator released an Inter-Agency report partnering with the Food and Drug Administration, U.S. Customs and Border Protection, U.S. Immigration and Customs Enforcement, and the Departments of Justice, State, and Commerce and USAID. The report highlights the Administration’s efforts to combat counterfeit pharmaceuticals listing various Department initiatives and in some cases providing actual budget numbers (State Department budgets $1.3 million in 2011 to combat counterfeit pharmaceuticals).  Finally, the report Read More >

Patently BIOtech  |  1 Comment  |  Email This Post
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FDA Sets VMAC Meeting to Consider Genetically Engineered Salmon

The U.S. Food and Drug Administration (FDA) announced today it will convene its Veterinary Medicine Advisory Committee (VMAC) to consider a salmon that has been genetically engineered to reach its market weight in half the time of conventionally raised salmon.  The VMAC meeting, part of a rigorous regulatory process required to assess such technologies before being approved for commercialization is scheduled for September 19-20.  At this meeting, the Committee will hear from independent experts about Read More >

Farmer Gene  |  2 Comments  |  Email This Post
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