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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
An increased number of generic appeals has led CDER to transfer the management of its Formal Dispute Resolution program for sponsors of user fee products from the Office of New Drugs to the Office of Executive Programs, CDER Director Janet Woodcock said in a staff memo. Read More
Institutional Review Boards must comply with the Code of Federal Regulations in their written procedures but they have some flexibility with regard to the format and content, according to new HHS guidance. Read More
ANDA applications remain sluggish while generic drug approvals creep upward after a drop at the start of the year, the FDA said, reporting 67 generic approvals and 57 ANDA applications for May. Read More
The FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility. Read More
Australia’s Therapeutic Goods Administration revised its guidelines for confidentiality obligations and conflicts of interest for members of advisory committees, overhauling the guidance with major content and structural changes. Read More
The FDA’s draft guidance on inclusion of pregnant women in clinical trials needs some fine tuning, according to stakeholders, including more clarity on non-adherence to therapies. Read More
The FDA has cut the amount of time it takes to issue post-inspection classification letters nearly in half over the past three years, according to one of the agency’s top inspection officials. Read More