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TXT Andropharm Recalls Products Containing Steroids [95 Words] [ Price : $8.95]
Andropharm recalls all lots of Sten Z and M1 Alpha capsules because they contain derivatives of anabolic steroids, which makes them unapproved drugs.
07/12/2017
 
 
TXT Mallinckrodt Paying $35 Million to Settle Opioid Allegations [2833 Words] [ Price : $8.95]
The Justice Department says that Mallinckrodt is paying $35 million to resolve allegations that it failed to report suspicious oxycodone sales to the Drug Enforcement Administration.
07/12/2017
 
 
TXT NC Federal Court Upholds Preemption in Essure Case [2731 Words] [ Price : $8.95]
Attorney Michelle Yeary says a North Carolina federal court made the correct decision in determining that a failure-to-warn claim against Bayer’s Essure birth control device was preempted.
07/12/2017
 
 
TXT FDA Priority Review on Lilly NDA for Abemaciclib [134 Words] [ Price : $8.95]
FDA accepts for priority review an Eli Lilly NDA for abemaciclib, a cyclin-dependent kinase 4 & 6 inhibitor for two indications in breast cancer.
07/12/2017
 
 
TXT Hearing Debates Pros/Cons of Increased Off-label Communications [1314 Words] [ Price : $8.95]
A House Energy and Commerce subcommittee hears differing opinions on whether to advance two bills that would open up FDA’s regulatory framework to allow more dissemination of truthful and non-misleading off-label information about drugs and devices.
07/12/2017
 
 
TXT FDA User Fee Reauthorization Passes House on Voice Vote [117 Words] [ Price : $8.95]
The House of Representatives passes a bill (voice vote) to reauthorize medical product user fee programs for another five years beginning 10/1.
07/12/2017
 
 
TXT CGMP Violations at India’s Vista Pharmaceuticals [2790 Words] [ Price : $8.95]
FDA warns India’s Vista Pharmaceuticals about CGMP and misbranding violations in its production of a finished pharmaceutical.
07/11/2017
 
 
TXT Comments Sought on Drug CMC Date Elements [165 Words] [ Price : $8.95]
Federal Register notice: FDA requests comment on draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control data elements and terminologies for electronic submission.
07/11/2017
 
 
TXT Reject Auryxia sNDA: Vifor Fresenius [2895 Words] [ Price : $8.95]
Vifor Fresenius asks FDA not to approve a Keryx sNDA for its Auryxia that would expand its market, citing to multiple safety concerns.
07/11/2017
 
 
TXT Regulatory Review Period Determination for Intercept Plasma Device [90 Words] [ Price : $8.95]
Federal Register notice: FDA determines that the regulatory review period for Cerus Corp.’s Intercept Blood System For Plasma is 6,497 days.
07/11/2017
 
 
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