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The Therapeutic Goods Administration is considering raising the threshold for classifying rare diseases, as well as the number of patients in specific subsets of a disease, to broaden the scope of drugs that qualify for orphan status. Read More
The House Energy & Commerce Committee passed the 21st Century Cures Act on May 21, a measure that would extend the rare pediatric disease priority review voucher program from its current sunset date in March 2016 through December 2018. Read More
A slew of observations related to control records, data integrity and manufacturing at Dr. Reddy’s Andhra Pradesh, India, facility resulted in a Form 483. Read More
The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards. Read More
The committee members are pressing the FDA to expand the warnings on extended-release opioids to include immediate-release versions of the painkillers. Read More
The FDA wants drugmakers to assess the risks of active pharmaceutical ingredients taken by men on the development of embryos and fetuses of their female partners. Read More
Drugmakers under consent decrees with the FDA may be able to deduct some payments made as part of their settlement with the agency when they file their tax returns, according to an informal opinion by the Internal Revenue Service’s chief counsel. Read More
Merck and Samsung Bioepis said Wednesday that their biosimilars for Enbrel and Remicade both met primary endpoints in pivotal Phase 3 clinical trials, putting them on the path to filing regulatory submissions. Read More