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The AIDS Law Project of Pennsylvania has filed a class action lawsuit in California against Gilead Sciences after the drug maker sent envelopes to users of its HIV prevention drugs with the return address “HIV Prevention Team” in red lettering. Read More
The FDA spelled out in a new guidance released yesterday how it will conduct formal meetings and deal with new drug applications during the COVID-19 pandemic. Read More
A Seattle-based study of how COVID-19 spreads through the community has put its project on hold at the FDA’s request until it receives an Emergency Use Authorization (EUA) for its lab-developed test and self-swab kit. Read More
Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said yesterday that he still believes a COVID-19 vaccine could be deployed by the end of the year. 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
President Trump says he wants drug pricing legislation passed this year despite the coronavirus pandemic, according to Sen. Chuck Grassley (R-Iowa), the chairman of the Senate Finance Committee. Read More
The FDA added morphine sulfate and epinephrine to the list of compounded drugs under the agency’s temporary policy that allows outsourcing facilities to produce the drugs during the COVID-19 pandemic. Read More
The World Health Organization (WHO) has adopted a resolution calling for the voluntary sharing of patent rights and product data for COVID-19 countermeasures. Read More
HHS is defending the bidding process that led to its $354 million four-year contract with a Virginia-based startup to manufacture active pharmaceutical ingredients (APIs) and finished drugs for emergency situations. Read More