Gottlieb's FDA

Legal experts point to what they view as flaws in FDA's recently announced plan to alert the Federal Trade Commission (FTC) when brand-drug makers use the citizen petition process to delay generics from entering the market.

FDA plans to finalize in mid-2019 its nearly decade-old proposed rule mandating that direct-to-consumer prescription drug advertisements state the drug’s major side effects and risks in a “clear, conspicuous, and neutral manner,” according to the agency’s fall 2018 regulatory agenda released Tuesday (Oct. 16).

FDA on Tuesday (Oct. 16) issued a draft guidance in a bid to help drug firms share consumer-friendly efficacy and risk data in their direct-to-consumer (DTC) promotional labeling and advertisements.

FDA Commissioner Scott Gottlieb announced two new guidances Monday (Oct. 15) aimed at guiding industry on how to design clinical trials and medical products that use two new technologies: minimal residual disease (MRD) biomarkers and the tracking of molecular changes that cause diseases.

FDA's move toward developing more product-specific guidances rather than establishing policy through citizen petition responses may cause delays in agency policy development and leave industry left with unanswered questions, especially in the combination products space, one industry representative argued at a recent conference.

FDA released a slate of guidance documents on Tuesday (Oct. 9) aimed at advancing development of complex generic drug products, which tend to be more difficult to formulate, manufacture and “genericize” than other generics, FDA Commissioner Scott Gottlieb said Tuesday.

An array of stakeholders voiced their support for the cross-industry role laid out in a set of sweeping cybersecurity initiatives unveiled by FDA Commissioner Scott Gottlieb this week, including new cybersecurity information sharing agreements, a playbook for hospitals to prepare for cybersecurity breaches and plans for an updated agency guidance document.

The Senate cleared a massive bicameral package of opioid legislation on Wednesday (Oct. 3) by a vote of 98-1, with Sen. Mike Lee (R-UT) as the sole “no” vote, and Sen. Ted Cruz (R-TX) not voting.

Medical device industry experts said that a draft guidance released by FDA last week aimed at expanding the use of a faster premarket review program could, if finalized, be particularly useful for software companies, and would help the agency achieve its goal of reducing its average 510(k) review times.