Regulatory Affairs

Common Rule Revisions Delayed for Six Months

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 2018 Guidance Agenda Features Gene Therapies

CBER’s agenda for 2018 states that it is considering the release of more than a dozen guidance documents, including new draft guidance on testing retroviral gene therapy products and on hemophilia gene therapy, along with revisions to its draft guidance on reducing the risk of Zika virus transmission.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