Continuing the rollback of Obama-era policies, the Equal Employment Opportunity Commission (EEOC) hit pause on the collection of Employer Information
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the Food and Drug Administration's (FDA or "the Agency") Center for Devices and Radiological Health (CDRH) issued a draft guidance regarding the submission and review of petitions under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), also known as the de novo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.
On October 3, 2011, the FDA released draft guidance entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation).”
On October 3, 2011, the Food and Drug Administration issued a draft guidance clarifying its “de novo” review procedures and the data required for the submission and review of petitions asking FDA to reclassify certain medical devices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.”
The FDA's release of the de novo draft guidance last week is causing a stir, but does the newly created concurrent review really help save cost and time?
The U.S. FDA recently issued a draft Guidance document setting forth a streamlined, improved de novo petition process for medical devices.
On October 3, 2011, FDA issued a draft guidance entitled, “De Novo Classification Process (Evaluation of Automatic Class III Designation).”
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).
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.
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.