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French company prevails in dispute with FDA over drug-classification ruling
- Shook Hardy & Bacon LLP
- -
- 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
FDA brings successful enforcement actions against dietary supplement makers
- Shook Hardy & Bacon LLP
- -
- USA
- -
- 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
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
FDA warns competing drug makers over unsubstantiated superiority claims
- Shook Hardy & Bacon LLP
- -
- 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FDA draft guidance addresses safety labeling changes
- Shook Hardy & Bacon LLP
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- USA
- -
- April 21 2011
The Food and Drug Administration (FDA) has made available a draft guidance titled "Safety Labeling ChangesImplementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act," that would provide information on new statutory provisions authorizing the agency "to require certain drug and biological product application holders to make safety related labeling changes based upon new safety information that becomes available after the drug or biological product is approved."
Medical product companies ask FDA to clarify policies on off-label uses
- Shook Hardy & Bacon LLP
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- USA
- -
- July 14 2011
Leading U.S. pharmaceutical and medical device manufacturers have filed a citizen petition with the Food and Drug Administration (FDA) calling on the agency to clarify its regulations and policies on off-label uses of drugs and medical devices
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
FDA seizes probiotic products marketed as drugs
- Shook Hardy & Bacon LLP
- -
- USA
- -
- June 16 2011
The Food and Drug Administration (FDA) has reportedly seized probiotic products from a Minnesota-based company, alleging that they are being marketed as drugs
FDA proposes amendments to sterility testing for biological products
- Shook Hardy & Bacon LLP
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- USA
- -
- June 30 2011
The Food and Drug Administration (FDA) has issued a proposed rule amending the sterility test requirements for biological products, including vaccines and stem-cell treatments
Adequacy of generic drug warnings on U.S. Supreme Court agenda
- Shook Hardy & Bacon LLP
- -
- USA
- -
- April 7 2011
The U.S. Supreme Court is considering whether a generic drug maker can be held liable under state law for failing to include on its drug label safety information not yet used by name brand manufacturers or required by the Food and Drug Administration (FDA
Current Search
- Workarea - Healthcare
- Workarea - Product Liability
- Author - Madeleine McDonough
- Author - Thomas T. Moga
- Firm Name - Shook Hardy & Bacon LLP
- Jurisdiction - USA