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An Australian Therapeutic Goods Administration proposal to expand the information offered in its current naming system for biologics drew support from most respondents, with Mylan warning an alternate proposal to adopt suffixes may offer little benefit for pharmacovigilance. Read More
FDA Commissioner Scott Gottlieb spoke about the regulatory challenges of precision medicines and the agency’s plans to focus on durability and safety issues, in a panel discussion at the World Economic Forum in Davos, Switzerland. Read More
Drug sponsors can prove the effectiveness of combination drugs for treatment of hypertension with trials that test the highest approved dosage rather than trials with multiple doses, the FDA said in new draft guidance for developing such products. Read More
Commonly prescribed generic drugs in Canada will see a price cut of up to 40 percent in April as part of a new initiative by two drug industry groups. Read More
The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Read More
The federal government pushed back its revisions to the Common Rule for an additional six months — making the announcement less than 36 hours before the changes were set to take effect Jan. 19 — and warned the public to expect additional delays down the line. Read More
CBER’s agenda for 2018 states that it is considering the release of more than a dozen guidance documents, including new draft guidance on testing retroviral gene therapy products and on hemophilia gene therapy, along with revisions to its draft guidance on reducing the risk of Zika virus transmission. Read More
CDER published an agenda of 98 upcoming draft guidances for the 2018 calendar year — including new recommendations for developing treatments for Alzheimer’s and amyotrophic lateral sclerosis. Read More
The FDA is prioritizing the opioid crisis, innovation, and generic competition in the coming year, the agency said in its 2018 Strategic Policy Roadmap. Read More
The FDA issued a direct final rule removing the biennial inspection requirement for biologics production facilities and adopting a more flexible, risk-based approach to how often the agency will conduct inspections. Read More
CDER and CBER issued a joint data standards strategy detailing how the centers will develop and use data standards to review pre- and post-market safety and efficiency data through fiscal year 2022. Read More
Citing a public health emergency, a group of congressional Democrats called on HHS Secretary Alex Azar to use existing legislative authority to lower the price of hepatitis C virus treatments. Read More