Latest News & Analysis
US FDA’s David Martin encourages sponsors to register observational studies on drug effectiveness to enhance transparency and agency confidence in the data.
Trial opens after settlement proposals by three distributors, Teva and J&J fail to gain support of cities and counties. Distributors want to call former FDA Commissioner Kessler to testify over plaintiffs' objections. Judge rules plaintiffs cannot seek future damages.
A timeline of the history of opioid litigation from Purdue Pharma's 2007 settlement to the bellwether trial in Ohio.
Offered as a failed amendment by House Energy & Commerce Committee’s ranking Republican during markup of Speaker Nancy Pelosi’s drug pricing bill, the proposal is in line with biopharma’s position on manufacturer price concessions in Part D and suggests a road map for the kind of bill that might pass the Senate.
Keeping Track: A Novel Approval For Fluorodopa F 18, A Tentative Approval For Vumerity, And A Missed Goal Date For Zilretta
The latest drug development news and highlights from our US FDA Performance Tracker.
An upcoming PDA technical report is expected to build on the concepts of an earlier report on laboratory systems and propose a risk-based approach for protecting data integrity using a nine-box grid for assessing data integrity risks.
Seven new products, including the world’s first ever Ebola vaccine, are on track to receive EU-wide approval. Meanwhile, two drugs have failed to make the grade.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Following on from moves to push price transparency on to the global agenda, Italy is poised to pass a decree that would oblige companies to disclose public R&D funding.
Efforts to ensure that supplies of medicines continue to flow if the UK leaves the EU without a deal have been stepped up with the announcement of three contracts to provide an express delivery service for urgently needed products.
Preliminary performance data suggests only a handful of applications receiving US FDA action by the end of FY 2018 actually missed their review goals.
Strict conflict of interest rules have hampered the agency's ability to fill advisory committee vacancies.
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