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Endo Pharmaceuticals agreed to settle more than 1,300 lawsuits over its testosterone replacement drug from a $200 million fund it set aside last year. The drugmaker announced a master settlement agreement that will resolve all current cases involving the drug, Testim, including multidistrict litigation involving about 900 lawsuits. Read More
A bill introduced in the House by Rep. Doris Matsui (D-Calif.) Wednesday would strengthen the 340B program to provide increased funding for anti-addiction efforts. 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
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The FDA’s draft guidance on inclusion of pregnant women in clinical trials needs some fine tuning, according to stakeholders, including more clarity on non-adherence to therapies.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
In an effort to curb the “gaming tactics” that delay generic drug competition, the FDA released a public list of companies found to be potentially restricting access to samples of their branded products. Read More
The FDA released the ICH’s Q12 draft guidance on pharmaceutical product lifecycle management (PLCM) for post-approval changes in chemistry, manufacturing and controls. Read More