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21 Jul 2015, 7:50 am by Kevin Madagan and Vicki Morris
 Subtitle I, Orphan Product Extensions Now; Incentives for Certain Products for Limited Populations – Would extend the exclusivity period for six months for an approved drug already on the market when FDA approves a new indication for the drug for a rare disease or condition. [read post]
19 May 2011, 10:47 am by Steven Hansen
Section 14(a)(1) of the CPSA requires that certifications for nonchildren's products be based on a test of each product or upon a reasonable testing program. [read post]
30 Nov 2023, 7:09 am by Don Asher
  For Powered Industrial Trucks, OSHA warns us all that the most common citations involved: 1910.178(l)(1): Safe operation. 1910.178(l)(4): Refresher training and evaluation. 1910.178(l)(6): The employer shall certify that each operator has been trained and evaluated as required by this paragraph (l). [read post]
29 Dec 2010, 2:57 am by Marie Louise
Holdings v Metabolite Labs (Patents Post Grant) US: District Court Arizona: Question of whether to incur ‘substantial expenses’ for testing and clinical trials does not create substantial controversy sufficient to assert declaratory relief claim: W L Gore & Assoc. v GI Dynamics (Docket Report) US: Correction of inventorship complaint: Salk Institute for Biological Studies v. [read post]