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Gottlieb Establishes Opioid Committee, Pledges to Limit Prescription Abuse Scott Gottlieb, in one of his first official acts as FDA commissioner, established an opioid policy steering committee to review the agency’s drug review policies and explore possible actions to lower abuse. Read More
Trump Proposes “Recalibration” of FDA Budget with $854 Million in Cuts President Trump’s budget for fiscal 2018 proposes a “recalibration” of how the FDA funds its core mission of ensuring the safety drugs, which would cut its federal spending by $854 million, to be replaced with $866 million in industry user fees. Read More
FDA Issues 21 New Product-Specific Draft Guidances for Generics, 16 Revised The documents describe the FDA’s recommendations for necessary in vivo and in vitro studies for each drug. Read More
Eleven Senate Democrats Warn Proposed Cuts Would Hurt Cures Act Implementation Trump’s budget blueprint for the next fiscal year seeks deep cuts to federal agencies. Read More
Automation of Process Control within the Pharmaceutical Industry While most pharmaceutical businesses have adopted process automation in one format or another, the technology has evolved considerably over the past few years, leading to improvements in design, efficiency and reliability. One of the major drivers for businesses to increase levels of automation is legislation, but the need to compete in the market place and reduce ... Read More