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September 20, 2017
The Food and Drug Administration has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2)...
August 1, 2017
On Friday, July 28, 2017, the FDA released a new, comprehensive plan concerning the regulation of tobacco and nicotine. This multi-year regulatory plan is part of the Agency’s attempt to protect...
July 19, 2017
On Tuesday, July 11th, FDA released its draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for the electronic submission of this...
July 12, 2017
On Friday, July 7th, the FDA approved Endari (L-glutamine oral powder) to reduce the complications associated with sickle cell disease in patients age five years and older. What is Sickle Cell...
June 16, 2017
On Wednesday, June 14th, the FDA announced plans to host a public workshop regarding the impact of opioid formulations with abuse deterrent properties. The workshop, entitled “Data and Methods for...
June 14, 2017
On Thursday, June 8th, the FDA requested that Endo Pharmaceuticals remove Opana® ER (oxymorphone hydrochloride), an opioid pain medication, from the market. History with FDA The FDA originally...
June 13, 2017
On Thursday, June 1st, the FDA issued a Warning Letter to Prestige Brands Holdings, an over-the-counter (OTC) drug manufacturer. PediaCare Children’s Plus Multi-Symptom Cold and PediaCare Children’s...
June 7, 2017
On Wednesday, June 7th, the FDA amended its final rule concerning humanitarian use devices (HUDs). The amendments to the regulations are being made in response to changes recently enacted into law by...
June 5, 2017
On Tuesday, May 30th, Indivior Plc., a British company focused on addiction treatment, submitted a New Drug Application (NDA) to the FDA for its investigational drug intended to treat...