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After a flurry of opioid- related bills passed the House earlier last week, the chamber on Friday passed legislation that will limit the availability of synthetic drugs. Read More
The FDA released a list of alternative suggestions for complying with CGMP requirements for drug combination products that covers stability testing, release for distribution, reserve samples and special testing requirements. Read More
Representatives from the FDA and the European Medicines Agency discussed further opportunities for collaboration in their 2018 annual meeting. Read More
The European Medicines Agency proposes to merge two guidances on clinical evaluations of bacterial infection treatments to reflect the latest scientific advice from its Committee for Medicinal Products for Human Use. Read More
Australia’s Therapeutic Goods Administration updated its plan for mandatory drug shortage reporting based on public comments in response to an April request. Read More
HHS issued a final rule to once again delay implementation of the revised Common Rule on the protection of human subjects in clinical trials for six months until Jan. 21, 2019, and to permit an exception from the existing federal policy for three burden-reducing provisions during the delay period. Read More
The European Medicines Agency launched its new online portal for orphan designation applications and is strongly encouraging companies to start using the portal right away, although it will not fully replace the existing submission process until the fall. Read More
The Association for Accessible Medicines urged the FDA to clarify its draft guidance on Drug Supply Chain Security Act (DSCSA) waivers by adding an estimated timetable for review decisions. Read More
The European Medicines Agency expressed “serious concerns” about drugmakers’ preparedness for the UK’s departure from the European Union in a report released Tuesday. Read More