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The House voted 224 to 189 Friday to pass a fiscal 2021 appropriations bill that would give the FDA $3.2 billion in funding, an increase of $40.8 million from fiscal 2020. Read More
Sponsors and manufacturers will have to provide the FDA an annual summary of their compassionate use drug administration under a proposed agency rule released yesterday. Read More
Since February, the FDA has approved nearly 300 manufacturing changes to help speed drugs to market for COVID-19 patients, FDA Commissioner Stephen Hahn said this week. He was touting the agency’s prompt response to the pandemic. Read More
Clinical research on human drugs that contain cannabis can be conducted legally as long as the amount of the substance in the investigational product is within limits set by a new FDA draft guidance. Read More
The Department of Justice announced yesterday that two Chinese hackers have been indicted on charges of trying to hack COVID-19 vaccine research in the U.S. Read More
As a result of the COVID-19 pandemic, the FDA has extended its enforcement discretion policy for six months for manufacturers of stem cell products to submit marketing applications to the FDA. Read More
The British government announced Monday that it has reached COVID-19 vaccine supply deals with Pfizer/BioNTech and Valneva, locking in tens of millions of doses of their vaccine candidates for the country. Read More
Democrats on the House’s coronavirus crisis subcommittee have launched an investigation into federal contracts for producing drugs, drug ingredients and supplies essential in the pandemic that they claim have been awarded to businesses politically tied to the Trump administration “without competition or transparency.” Read More
Teva Pharmaceuticals will be front and center in the first bellwether trial over an alleged industrywide generic drug price fixing conspiracy, a federal judge for the U.S. District Court for the Eastern District of Pennsylvania has ruled. Read More