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The far reach of California Proposition 65

Hodgson Russ LLP
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USA
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March 22 2013

In 1986, California voters approved an initiative to address their growing concerns with exposure to toxic chemicals. That initiative became the Safe

FDA's final rule for combination products

Hodgson Russ LLP
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USA
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January 29 2013

On January 22, 2013, the Food and Drug Administration (FDA) issued a final rule on current good manufacturing practice (CGMP) requirements applicable

Another victory for FDA, bigger warning for regulated industry

Hodgson Russ LLP
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USA
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July 12 2012

On July 2, British drug maker GlaxoSmithKline agreed to plead guilty and pay a $3 billion fine for its off-label marketing of three drugs and for its failure to comply with the FDA’s post-marketing reporting requirements for one of its drugs

Device guidance update

Hodgson Russ LLP
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USA
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July 6 2012

Those of us practicing law or working in device regulatory compliance in the United States are not alone in our quest to better understand the mood and direction of the Centers for Device and Radiological Health (CDRH

IOM report on food and medical product safety from foreign sources highlights large-scale shortcomings

Hodgson Russ LLP
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USA
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April 24 2012

The Institute of Medicine (IOM) Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries recently issued a report entitled “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad.”

Requests for information: Section 513(g) submissions have pros and cons

Hodgson Russ LLP
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USA
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April 13 2012

The FDA continues to push its regulatory agenda and priorities primarily through guidance rather than notice and comment rulemaking

Labeling, advertising, and promotion of medical products

Hodgson Russ LLP
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USA
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April 9 2012

Proper labeling of products regulated by the FDA is extremely crucial

FDA and FTC issue warnings for illegal homeopathic weight-loss remedies

Hodgson Russ LLP
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USA
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December 20 2011

At the end of November, the Food and Drug Administration (FDA) issued warning letters to seven companies marketing diet products containing human chorionic gonadotropin (hCG

Implantable device warranty compliance audits gain momentum

Hodgson Russ LLP
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USA
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November 16 2011

Device warranties often entitle providers to the full replacement of a device or a credit toward the device cost during a warranty period

Utilizing the concurrent de novo review

Hodgson Russ LLP
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USA
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October 11 2011

The FDA's release of the de novo draft guidance last week is causing a stir, but does the newly created concurrent review really help save cost and time?

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