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Leading drug firms and PhRMA have weighed in on the FDA’s plan to study the risks and benefits of online prescription drug communications and the possible impact of space limitations such as Twitter’s 140-character limit. Read More
Italian regulatory authorities have ordered a ban on drug substances and bulk products manufactured by Antibióticos Do Brasil after an inspection revealed several GMP deficiencies, ranging from data integrity to quality management issues. Read More
PhRMA is urging the USPTO to reevaluate patent eligibility for prescription drugs to provide the drug industry a better framework for interpreting regulations and recent case law. Read More
Democratic members of Congress have asked President Trump how the federal hiring freeze will affect the FDA’s user fee program, which are set to be reauthorized later this year. They account for 42 percent of the agency’s budget. Read More
President Donald Trump hosted the leaders of PhRMA for a White House meeting on the state of the pharmaceutical industry and the FDA, saying that drug prices have been “astronomical” and pledging cuts to regulations. Read More
Eight Democratic senators have sent a letter to the FDA, airing their concerns over the effects of the government-wide hiring freeze on the agency’s mission. Read More
The FDA and other government agencies are being ordered to identify two regulations to be eliminated for each new one they propose and to reconsider the industry’s costs of compliance, according to an executive order issued by President Donald Trump. Read More