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House appropriators concerned about sequestration of FDA user fees

Shook Hardy & Bacon LLP
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USA
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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
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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
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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
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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
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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
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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
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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

Senate committee approves bill aimed at improving safety of drugs, devices for kids

Shook Hardy & Bacon LLP
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USA
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May 17 2012

The U.S. Senate’s Health, Education, Labor and Pensions Committee has reportedly approved a bill (S. 2289) aimed at making children’s medications and devices safer. Introduced by Senator Jack Reed (D-R.I.), the “Better Pharmaceuticals and Devices Act of 2012” is part of a larger package that includes provisions reauthorizing user fees for drugs, medical devices, generics, and biological products

Biopharma co. seeks $90 million for tainted raw material from China

Shook Hardy & Bacon LLP
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USA
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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