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Home » Topics » Regulatory

Regulatory
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Regulatory front for Jan. 24, 2020

Jan. 24, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Sage Therapeutics
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Anerem approved in Japan for general anesthesia

Jan. 24, 2020

Japanese approval for Corectim ointment for atopic dermatitis

Jan. 24, 2020

FDA grants accelerated approval of Tazverik for epithelioid sarcoma

Jan. 24, 2020

Dotinurad receives Japanese approval for hyperuricemia

Jan. 24, 2020

Regulatory front for Jan. 23, 2020

Jan. 23, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Cowen Washington Research Group, European Commission, GE Healthcare
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Gavel and scales

Securities class action suits a growing fact of life for life sciences

Jan. 23, 2020
By Mari Serebrov
Whether large or small, or based in the U.S. or abroad, life sciences companies are an increasingly attractive target for shareholder suits. The number of securities fraud class action suits filed in the U.S. in 2019 across all industries totaled 404, just one more than the 403 cases filed in 2018 and down from the peak of 412 in 2017, according to a new Dechert LLP report.
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Australia’s TGA proposes fee increases to implement recent drug, device reforms

Jan. 23, 2020
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.
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Regulatory front for Jan. 23, 2020

Jan. 23, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Insys
Read More

Japanese approval of Dinagest for dysmenorrhea

Jan. 23, 2020
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