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French company prevails in dispute with FDA over drug-classification ruling
- Shook Hardy & Bacon LLP
- -
- 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
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 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
Medical product companies ask FDA to clarify policies on off-label uses
- Shook Hardy & Bacon LLP
- -
- 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
European Court of Justice weighs in on GMOs
- Shook Hardy & Bacon LLP
- -
- European Union
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- September 22 2011
In recent weeks, the European Court of Justice (ECJ) has issued rulings in two cases involving genetically modified organisms (GMOs
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 seeks comments on adverse experience reporting for licensed biological products
- Shook Hardy & Bacon LLP
- -
- USA
- -
- May 5 2011
The Food and Drug Administration (FDA) is seeking public comment on the proposed collection of information concerning "requirements relating to FDA's adverse experience reporting (AER) for licensed biological products, and general records associated with the manufacture and distribution of biological products."
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
Australia and New Zealand to form joint drug, medical-device regulatory agency
- Shook Hardy & Bacon LLP
- -
- Australia, New Zealand
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- June 30 2011
The Australian and New Zealand governments have reportedly developed a five-year plan to create a joint agency that will regulate medicines, medical devices and new medical interventions, such as cellular therapy
FDA proposes amendments to sterility testing for biological products
- Shook Hardy & Bacon LLP
- -
- 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
Current Search
- Firm Name - Shook Hardy & Bacon LLP
- Author - Thomas T. Moga
- Author - Patrick Henderson
- Workarea - Product Liability