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Results:1-10 of 16

Drug compounding oversight bill advances in House
  • Shook Hardy & Bacon LLP
  • USA
  • October 3 2013

The U.S. House of Representatives has reportedly passed by voice vote a bill (H.R. 3204) to strengthen the Food and Drug Administration's (FDA's)


FDA publishes guidance on wireless technology in medical devices
  • Shook Hardy & Bacon LLP
  • USA
  • August 22 2013

The Food and Drug Administration (FDA) has published guidance titled "Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry


FDA proposes pilot program to test automated form for NDA submissions
  • Shook Hardy & Bacon LLP
  • USA
  • May 9 2013

The Food and Drug Administration (FDA) has announced a pilot program "to test an XML (extensible markup language)-enabled Adobe PDF form, Form FDA


FDA proposes regulations for stand-alone symbols on medical devices
  • Shook Hardy & Bacon LLP
  • USA
  • April 25 2013

The Food and Drug Administration (FDA) has proposed revising medical device and biological product labeling regulations "to explicitly allow for the


FDA announces public meeting to discuss cosmetics regulation
  • Shook Hardy & Bacon LLP
  • USA
  • April 11 2013

The Food and Drug Administration (FDA) has scheduled a May 8, 2013, public meeting in College Park, Maryland, "to invite public input on various


OEHHA proposes adding clomiphene citrate to Prop. 65 list
  • Shook Hardy & Bacon LLP
  • USA
  • April 11 2013

California EPA's Office of Environmental Health Hazard Assessment (OEHHA) has issued a notice of intent to list clomiphene citrate as a chemical


U.S. House Reps. introduce the Safe Cosmetics and Personal Care Products Act
  • Shook Hardy & Bacon LLP
  • USA
  • April 11 2013

U.S. Reps. Edward Markey (D-Mass.) and Jan Schakowsky (D-Ill.) recently introduced the Safe Cosmetics and Personal Care Products Act of 2013 (H.R


MDL court rejects primary jurisdiction defense in hand soap antibacterial lawsuits
  • Shook Hardy & Bacon LLP
  • USA
  • March 28 2013

A federal multidistrict litigation (MDL) court in New Hampshire has denied the motion to dismiss filed by the defendant in consolidated class actions


Second Circuit allows suit against FDA over antibacterial chemical in some soaps
  • Shook Hardy & Bacon LLP
  • USA
  • March 28 2013

The Second Circuit Court of Appeals has determined that the Natural Resources Defense Council (NRDC) has standing to bring an action against the Food


GAO issues report on FDA oversight of dietary supplements
  • Shook Hardy & Bacon LLP
  • USA
  • March 28 2013

The U.S. Government Accountability Office (GAO) has issued a report titled "Dietary Supplements: FDA May Have Opportunities to Expand Its Use of