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381 results found

Article

Manatt Phelps & Phillips LLP | USA | 21 Sep 2017

More Obama-Era PoliciesPay Data Collection, Overtime RuleFall

Continuing the rollback of Obama-era policies, the Equal Employment Opportunity Commission (EEOC) hit pause on the collection of Employer Information

Article

Hogan Lovells | USA | 21 Oct 2011

FDA issues new draft guidance on de novo classification process

On Monday, 3 October 2011, the Food and Drug Administration's (FDA or "the Agency") Center for Devices and Radiological Health (CDRH) issued a draft guidance regarding the submission and review of petitions under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), also known as the de novo classification process.

Article

Reed Smith LLP | USA | 14 Oct 2011

FDA issues draft guidance to clarify de novo classification process

On October 3, 2011, the FDA released draft guidance entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation).”

Article

Arnall Golden Gregory LLP | USA | 12 Oct 2011

New FDA guidance promises streamlined re-classification of Class III medical devices

On October 3, 2011, the Food and Drug Administration issued a draft guidance clarifying its “de novo” review procedures and the data required for the submission and review of petitions asking FDA to reclassify certain medical devices currently designated as “Class III.”

Article

Hodgson Russ LLP | USA | 11 Oct 2011

Utilizing the concurrent de novo review

The FDA's release of the de novo draft guidance last week is causing a stir, but does the newly created concurrent review really help save cost and time?

Article

Barnes & Thornburg LLP | USA | 7 Oct 2011

FDA issues draft guidance on improved de novo petition process for medical devices

The U.S. FDA recently issued a draft Guidance document setting forth a streamlined, improved de novo petition process for medical devices.

Article

King & Spalding LLP | USA | 5 Oct 2011

FDA issues draft guidance on de novo classification process

On October 3, 2011, FDA issued a draft guidance entitled, “De Novo Classification Process (Evaluation of Automatic Class III Designation).”

Article

Borden Ladner Gervais LLP | USA | 29 Sep 2011

DC Circuit court nixes SEC proxy rule requiring inclusion of shareholder nominees

The US Court of Appeals for the District of Columbia Circuit has vacated a SEC rule which would have required companies and investment companies to include, under certain circumstances, the names of shareholder nominees for board positions in their proxy materials: Business Roundtable v Securities and Exchange Commission (DC Cir. 22 July 2011).

Article

Gowling WLG | Canada | 14 Apr 2011

Apotex Inc. v. Minister of Health (2011 FCA 86) Apo-ASA, March 8, 2011

The Court of Appeal upheld a decision dismissing Apotex' application for judicial review of a Minister of Health decision refusing to issue a NOC for Apotex enteric-coated ASA.

Article

McCarter & English LLP | USA | 14 Dec 2010

Avoiding surprises involving ownership of intellectual property rights

The ongoing dispute involving ownership of the Bratz doll line has attracted significant attention in the marketplace at least in part based on plaintiff's damage claim of more than $1 billion.

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