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Responding to charges that the justifications for dramatic drug price increases to fuel expenses are “baseless,” the heads of Amgen, Mallinckrodt and Novartis told lawmakers Thursday they are willing to pull back in some instances on continuing steep price hikes. Read More
The House Oversight Committee has released two new staff reports from its ongoing drug pricing investigation that shed light on the tactics employed by Bristol Myers Squibb, Celgene and Teva Pharmaceuticals to raise the prices of two blockbuster drugs and turn massive profits, the same day committee Democrats grilled the company’s CEOs at its drug pricing hearing. Read More
Former FDA Commissioner Mark McClellan says it’s possible that a COVID-19 vaccine will be available for some portions of the population before year’s end but that it was never realistic to expect one before the Nov. 3 presidential election. Read More
Canadian Prime Minister Justin Trudeau said he is willing to consider U.S. plans for importing prescription drugs from Canada but that the needs of his own country come first. Read More
The House of Representatives yesterday passed a bipartisan bill in a voice vote to extend the FDA’s rare pediatric drug priority review voucher program by four years. Read More
The FDA has issued Aquestive Therapeutics a complete response letter (CRL) for its Libervant (diazepam buccal film) for the management of seizure clusters. Read More
The FDA’s safety program designed to reduce opioid abuse and misuse is not well suited to tackling the continuing epidemic in the U.S., mainly due to a lack of cooperation from makers of opioids, the HHS Office of the Inspector General (OIG) says is a new report. Read More
There is no sign of a slowdown in letters to the FDA seeking assurances that the agency will not bend to political pressure to approve a COVID-19 vaccine ahead of the Nov. 3 presidential election. Read More
Philip Krause, deputy director of the FDA’s Office of Vaccines Research and Review, said this week that the fate of the agency’s guidance on its expectations for COVID-19 vaccine Emergency Use Authorization (EUA) remains uncertain as it goes through the White House’s review. Read More
The FDA has issued two guidances to help generic drug applicants through the abbreviated new drug application (ANDA) process, including a final guidance on the preferred timing and content for changes to tentatively approved applications. Read More
Australia plans to make more in vitro diagnostic (IVD) self-tests available for infectious diseases like influenza beginning Oct. 1, although self-tests for cancer and genetic testing will not be allowed to be sold to consumers, the Therapeutic Goods Administration (TGA) said. Read More
Operation Warp Speed, the Trump administration’s COVID-19 vaccine and treatment initiative, is in “full alignment” with the FDA raising the bar on what’s required for an Emergency Use Authorization of a COVID-19 vaccine, the top adviser to the initiative says. That contradicts what President Trump has been saying. Read More