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House appropriators concerned about sequestration of FDA user fees
- Shook Hardy & Bacon LLP
- -
- USA
- -
- May 2 2013
Food and Drug Administration (FDA) Commissioner Margaret Hamburg reportedly testified before a House Appropriations Subcommittee about the effects of
Hawaii Senate shelves proposal to require labels for imported GE foods
- Shook Hardy & Bacon LLP
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- USA
- -
- April 4 2013
Three Hawaii Senate committees have deferred consideration of a House Bill (H.B. 174) that would have prohibited the sale of any "imported
IOM publishes report on the effects of falsified and substandard medicines
- Shook Hardy & Bacon LLP
- -
- Global, USA
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- February 21 2013
At the request of the U.S. Food and Drug Administration (FDA), national think tank the Institute of Medicine (IOM) has published a report that
FDA considers changes to generic drug labeling rules
- Shook Hardy & Bacon LLP
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- USA
- -
- February 21 2013
A footnote in an amicus brief filed by the U.S. Department of Justice (DOJ) in a case involving whether a design-defect claim asserted against a
Researchers question accuracy of generic drug safety labeling
- Shook Hardy & Bacon LLP
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- USA
- -
- January 10 2013
According to Regenstrief Institute researchers, despite U.S. Food and Drug Administration (FDA) requirements that generic medications bear warnings
FDA warns competing drug makers over unsubstantiated superiority claims
- Shook Hardy & Bacon LLP
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- USA
- -
- November 15 2012
The U.S. Food and Drug Administration has sent warning letters to competing drug manufacturers for allegedly promoting their neonatal respiratory distress syndrome treatments using “unsubstantiated superiority claims” that also “omit and minimize important risk information, and present unsubstantiated claims for the drug product”
FDA brings successful enforcement actions against dietary supplement makers
- Shook Hardy & Bacon LLP
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- USA
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- November 1 2012
The U.S. Food and Drug Administration (FDA) has obtained a permanent injunction against Truman Berst who sells, as Alternative Health & Herbs Remedies, herbs and dietary supplements with disease-treatment claims
French company prevails in dispute with FDA over drug-classification ruling
- Shook Hardy & Bacon LLP
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- USA
- -
- October 3 2012
A federal court in the District of Columbia has determined that the Food and Drug Administration (FDA) erred when it classified a combination drug-device product as primarily a drug, thus subjecting its French manufacturer to more burdensome regulatory requirements
Biopharma co. seeks $90 million for tainted raw material from China
- Shook Hardy & Bacon LLP
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- USA
- -
- May 3 2012
A biopharmaceutical company has sued companies in its supply chain, alleging they were negligent or vicariously liable for obtaining from China a raw material, contaminated with beef broth and avian products, for use in the creation of a bacterial master cell bank for the production of a biologic drug that will be used in patients with acute spinal cord injury
California initiates voter petition seeking mandatory labeling on biotech foods
- Shook Hardy & Bacon LLP
- -
- USA
- -
- January 19 2012
A group of environmentalists is reportedly seeking to qualify a voter initiative in California that would require special labels on foods containing genetically engineered (GE) ingredients
Current Search
- Author - Madeleine McDonough
- Author - Patrick Henderson
- Firm Name - Shook Hardy & Bacon LLP
- Jurisdiction - USA
- Workarea - Healthcare
- Workarea - Product Liability