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Citing a substantially increased volume of requests for expanded access to investigational drugs to treat COVID-19, the FDA has issued a final guidance that clarifies the conditions under which it will consider sponsor and investigator requests for waivers from full IRB review. Read More
The Trump administration has reportedly selected five COVID-19 vaccine candidates from a list of 14 to be evaluated under Operation Warp Speed. The five frontrunners are being developed by Moderna, Johnson & Johnson, AstraZeneca, Merck and Pfizer. Read More
The FDA’s changes in response to the COVID-19 outbreak will lead to permanent improvements at the agency, predicts FDA Commissioner Stephen Hahn. Read More
Following considerable public outcry over potential conflicts of interest for government officials who are working on the Trump administration’s initiative to develop COVID-19 treatments and vaccines, Janet Woodcock is temporarily stepping down as director of the Center for Drug Evaluation and Research (CDER). Read More
A federal appeals court has ruled that Genentech must face a lawsuit filed by cancer treatment centers over its cancer blockbuster Herceptin (trastuzumab). Read More
The FDA issued a draft guidance answering commonly asked questions about the Orange Book, the agency’s reference book for generic drug substitutions, including how it deals with patent listings. Read More
Two watchdog groups are pressing the U.S. Office of Government Ethics to reclassify the “vaccine czar” position President Trump recently filled, making it a government job requiring disclosure of all conflicts of interest instead of a private contractor position not bound by disclosure regulations and criminal ethics laws. Read More
President Trump announced Friday that the U.S. will sever its financial ties to the World Health Organization (WHO), claiming the organization failed to implement requested reforms and was receiving an unfair proportion of its funding from the U.S. Read More
Top pharmaceutical executives pushed back yesterday against the World Health Organization’s plan for sharing patent rights and product data for COVID-19 countermeasures. Read More