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Robert D. Stone Alston & Bird LLP

Results 1 to 5 of 17



Health care reform *

USA - October 28 2010
September 23 marked the six-month anniversary of the enactment of health care reform.

Co-authors: Donald E. Segal, Kim McWhorter, Julie Klish Tibbets, Joshua L. Becker, Elinor A. Hiller.


FTC issues proposed updates to rules on environmental marketing claims *

USA - October 28 2010
This month, the Federal Trade Commission (FTC) issued proposed modifications to update its so-called "Green Guides"-i.e., Guides for the Use of Environmental Marketing Claims found in 16 C.F.R. Part 260.

Co-authors: Donald E. Segal, Kim McWhorter, Julie Klish Tibbets, Joshua L. Becker, Elinor A. Hiller.


The future of medical product approvals: parallel review by FDA and CMS? *

USA - October 28 2010
Last month, FDA and the Centers for Medicare and Medicaid Services (CMS) issued a Federal Register notice soliciting comments on a proposal to establish a process for the parallel review of drugs and devices for FDA marketing approval or clearance and CMS national coverage determinations (NCDs).

Co-authors: Donald E. Segal, Kim McWhorter, Julie Klish Tibbets, Joshua L. Becker, Elinor A. Hiller.


Food safety reform *

USA - October 28 2010
As the 111th Congress comes to a close, comprehensive food safety reform remains unfinished due to Senate inaction resulting from member objections to the August manager's amendment to S.510.

Co-authors: Donald E. Segal, Kim McWhorter, Julie Klish Tibbets, Joshua L. Becker, Elinor A. Hiller.


FDA issues new guidance on research not requiring an IND *

USA - October 28 2010
In October, FDA issued a draft guidance entitled "Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can be Conducted Without an IND."

Co-authors: Donald E. Segal, Kim McWhorter, Julie Klish Tibbets, Joshua L. Becker, Elinor A. Hiller.


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