Drugs

Patient Advocate Urges Safety Metrics in PDUFA, GDUFA Deals

Patient-safety advocate Suzanne B. Robotti is calling for stronger postmarket safety and drug-quality accountability measures to be added to the upcoming reauthorization of the brand and generic drug user fee programs. Writing in an 10/1 MedShadow opinion piece, Robotti said she urged FDA during September public meetings on PDUFA and GDUFA reauthorizations to mandate safety and quality metrics into the agreements, arguing that industry obligations should receive greater attention after products reach the market.

Robotti, founder and president of MedShadow, said FDA faces specific performance deadlines for application reviews and interactions with drug companies, while manufacturers may face less accountability when postmarket safety reports or required follow-up studies are delayed.

She also highlighted manufacturing concerns involving generic drugs, including potency, dissolution and contamination problems, and argued that FDA and manufacturers need to respond more rapidly to emerging safety signals.

“Speed cannot be the only measure of success,” Robotti wrote, arguing that the next PDUFA and GDUFA agreements should strengthen protections after drugs reach the market as well as mechanisms intended to expedite their review.

Committee to Protect Health Care: Don’t Approve Overton

The Committee to Protect Health Care has sent a letter signed by over 2,500 physicians to members of the Senate, urging them to reject the Trump administration’s nomination of Heidi Overton to be FDA commissioner. “Dr. Overton’s dangerous record on vaccines and extremist anti-abortion advocacy are

Talk to FDA Early About Foreign Clinical Data: Analysis

While FDA is stepping up scrutiny of foreign clinical trials, particularly studies conducted outside an IND (see earlier story), drug sponsors should discuss their plans to rely on foreign data with FDA early in development, including at pre-IND meetings, and put greater emphasis on site selection, monitoring, investigator training

CDRH Proposed Guidances for FY 2027

CDRH has released its list of proposed guidances for FY 2027. The document separates the proposed guidances into three lists: * A List — priority guidance documents the Center intends to publish in FY 2027; * B List — guidance documents CDRH intends to publish as resources permit during FY 2027; and * Under Construction

14 Observations on Houston Rx FDA-483

FDA has released the Form FDA-483 issued following an 8/20-8/28 inspection at Houston Rx, a Houston, TX, producer of sterile drugs. The 14 inspection observations were: * personnel performed aseptic manipulations with exposed hair or skin; * a pattern of frequent or acute pressure reversals was observed from

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Committee to Protect Health Care: Don’t Approve Overton

Talk to FDA Early About Foreign Clinical Data: Analysis

CDRH Proposed Guidances for FY 2027

14 Observations on Houston Rx FDA-483