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The US Food and Drug Administration's Center for Drug Evaluation and Research and Office of Regulatory Affairs will soon launch an effort to streamline the two offices' inspection and facility evaluation efforts...CDER Director Janet Woodcock and Associate Commissioner for Regulatory Affairs Melinda Plaisier said it is vital that the two offices quickly implement the plan in order to meet commitments under the recently reauthorized user fee agreements, specifically citing the agency's promise to communicate final inspection classifications to generic drugmakers within 90 days of an inspection beginning in October 2018...We plan to operationalize the plan in the fall of 2017 for nearly all human drugs...FDA details the plan—which includes specific operating models for pre- and post-approval inspections, surveillance inspections and for-cause inspections—in a 20-page white paper obtained by Focus entitled Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations...

Birth-control delivery services have understandably been on the rise, with each one trying to combine the best medical, financial and legal fit for patients in mobile form. A new app on the scene aims to streamline both process and cost for users by eliminating the pharmaceutical middleman and shipping wholesale medicine direct from its home base to patients' own...The Pill Club is on a mission to make getting birth control as easy and cost-effective as possible, and even fun...founder Nick Chang...these goals are made possible by a fundamental difference between his app and others on the market--namely, that it provides all prescriptions and products in-house, without needing to involve the pharmacies and pharmacy prices that many users are looking to avoid...serving as its own functional pharmacy is what will allow The Pill Club to make the difference for patients who want to acquire birth control but have faced all-too-common hurdles to getting it…I always saw that there were a number of hurdles facing women getting access to birth control. There are structural ones, such as needing to go to the doctor for a prescription, and visiting pharmacies again and again to fill that prescription...what we set out to do: to connect telemedicine with telepharmacy...