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Gottlieb's FDA

October 18, 2018 | Daily News

FDA plans to “very quickly” begin implementing requirements that opioid makers package their drugs in unit-dose packaging to provide for shorter duration prescriptions, such as one or two days, agency commissioner Scott Gottlieb said Thursday (Oct. 18).

October 18, 2018 | Daily News

FDA and the Department of Homeland Security (DHS) have agreed to formally work together to stave off cybersecurity threats facing medical devices.

October 18, 2018 | Daily News

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.

October 18, 2018 | Daily News

A device industry lawyer expressed guarded confidence in a draft guidance FDA released last month that aims to revamp the agency’s 510(k) third-party review program, where qualified organizations review 510(k) submissions for certain low-risk devices.

October 17, 2018 | Daily News

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).

October 17, 2018 | Daily News

FDA is planning to move forward on a series of regulatory actions in the tobacco space, including proposing a ban on characterizing flavors in all cigars, according to the agency’s fall 2018 regulatory agenda, released Tuesday (Oct. 16).

October 16, 2018 | Daily News

FDA on Tuesday (Oct. 16) issued a draft guidance in a bid to help drug firms share consumer-friendly efficacy and risk data in their direct-to-consumer (DTC) promotional labeling and advertisements.

October 16, 2018 | Daily News

An FDA advisory committee on Friday (Oct. 12) determined that the benefits of a proposed new sufentanil sublingual tablet support the product's approval, overriding three panel members who disagreed.

October 15, 2018 | Daily News

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.

October 12, 2018 | Daily News

FDA sent letters to 21 e-cigarette companies to find out whether more than 40 products, including some flavored e-cigarette products, are being marketed illegally and outside the agency's current premarket compliance policy, the agency announced Friday (Oct. 12).

October 11, 2018 | Daily News

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.

October 10, 2018 | Daily News

Three Democratic senators wrote to top FDA officials Wednesday (Oct. 10) that they have “serious concerns” about the agency's emerging precertification program, where precertified software developers would not be subject to premarket review.

October 09, 2018 | Daily News

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.

October 05, 2018 | Daily News

Consumer advocates claimed victory after successfully petitioning FDA to de-list six carcinogenic flavoring chemicals from its food additives list over 50 years since their initial approval, effectively banning the substances from being used in food. FDA also de-listed a seventh chemical due to its falling out of use in industry.

October 04, 2018 | Daily News

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.

October 04, 2018 | Daily News

A device industry lawyer said FDA's recent speedy clearance of two Apple medical devices designed to detect atrial fibrillation -- announced the same day as a major Apple product launch Sept. 12 -- is the first time the agency appears to have coordinated its review process with a company launch.

October 03, 2018 | Daily News

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.

October 02, 2018 | Daily News

FDA warned brand drug makers Tuesday (Oct. 2) that it will alert the Federal Trade Commission (FTC) and Congress if it determines that a citizen petition was submitted primarily to delay approval of a generic drug application.

October 02, 2018 | Daily News

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.

October 01, 2018 | Daily News

FDA Commissioner Scott Gottlieb announced three new initiatives aimed at increasing cybersecurity preparedness and information-sharing among medical device stakeholders, particularly among health care delivery organizations (HDOs) such as hospitals.