Ethics/Regulatory

FDA to eliminate Orphan designation backlog

Thursday, June 29, 2017

The FDA has unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to all new requests for designation within 90 days of receipt during his testimony before a Senate subcommittee.

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Colorado passes Bill that allows medical cannabis treatments for PTSD

Monday, June 12, 2017

The Colorado General Assembly recently approved SB 17-17 to add Post-Traumatic Stress Bill to the list of approved medical conditions for the use of medical cannabis. That became Colorado law June 5th with Governor John Hickenlooper’s signature. This is the final step of what has been a long journey to justice. Military veterans and all suffering from this debilitating condition can finally have access to medical cannabis in order to effectively supplement their treatment regimen under the supervision of trusted physicians. Related Colorado Appeals and Denver District court cases were handled pro bono by Hoban Law Group on behalf of Plaintiffs Curtis Bean, Larisa Bolivar, Matthew Kahl, Stephen Otero and Zachary Phillips.

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FDA requests removal of Opana ER for risks related to abuse

Monday, June 12, 2017

The FDA requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

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Envigo facilities in Hyderabad, India gain AAALAC accreditation

Monday, June 5, 2017

Envigo has announced that its Research Models and Services (RMS) facility in Hyderabad, India, has been granted full accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International Council. In a letter to Envigo, AAALAC notified the company that it had met all the conditions required for full accreditation and commended the high quality facility and expertise of its people.

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