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The Legal Intelligencer

FDA Poised to Enact Rule That Will Advance Consumer Safety

On March 27, the U.S. Food and Drug Administration held a public meeting regarding its proposed generic-drug labeling rule. The rule proposed by the FDA in November 2013, titled "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products," would allow a generic manufacturer to use the CBE-0 process to implement a safety-related labeling change for its drug unilaterally, prior to the FDA approving the label change.
4 minute read

Connecticut Law Tribune

Fungus Based Food Company in Conn. Hit by Repeated Lawsuits

When vegetarians and other diet-conscious eaters go to the supermarket in search of healthy alternatives to meat, the optimal word is healthy. For more than a decade, a British company with U.S. headquarters in Connecticut has tried to tap into that market with meatless dinner entrees.
6 minute read

Connecticut Law Tribune

Conn. To Share In Pharmaceutical Kickback Settlement

A global pharmaceutical company has agreed to a $39 million settlement with the federal government and 49 states, including Connecticut, over allegations that its executives paid kickbacks to induce physicians to prescribe drugs.
3 minute read

Connecticut Law Tribune

Four Conn. Firms File Suits Against Pharmaceutical Maker

Hundreds of lawsuits have been filed nationally against the makers of Xarelto, a blood thinner that is alleged to cause uncontrollable and sometimes fatal bleeding, are mounting nationally, and four Connecticut law firms have brought claims.
3 minute read

National Law Journal

Regulations Lag Behind 'Telehealth' Technology

Remote, 24-hour monitoring would allow Americans who need long-term care to "age in place" at home.
8 minute read

New Jersey Law Journal

Judge Says Medical Device Maker Immune From State Law Claims

State law claims against Medtronic Inc. for products liability and negligence concerning its Activa Deep Brain Stimulation System are preempted by federal law because the device received premarket approval from the U.S. Food and Drug Administration, a federal judge in Camden, New Jersey has ruled.
5 minute read

National Law Journal

Changes Ahead as FDA Awaits New Leadership

The creation of a new food-safety agency and increased testing oversight are possibilities.
4 minute read

National Law Journal

Generics and Biosimilars Catch the FDA's Eye

By | February 16, 2015
These drug regulation issues that garnered attention last year and will remain relevant in 2015 even as the FDA transitions to new leadership.
6 minute read

National Law Journal

Generics' Immunity from Lawsuits In Jeopardy

A proposal by the Food and Drug Administration would expose drugmakers to personal-injury liability.
7 minute read

Corporate Counsel

Not All Fun, but Not Bad

Mary Jane Saunders: General Counsel | Beer Institute
3 minute read

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