Devices

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 List — guidance documents that CDRH intends to develop as resources permit and that are not on the A- or B-list.

The A list contains seven final guidance topics and one draft guidance topic. The B list has three final guidance topics and two draft guidance topics. The Under Construction list has four topics.

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

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

FDA Updates ICH Standard for Electronic Safety Reports

FDA has posted an updated final guidance describing the international technical standard for electronically transmitting individual case safety reports, incorporating technical changes made to the ICH E2B(R3) implementation guide in 2025. The guidance, entitled “E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide — Data Elements and

Drug User Fee Agreement Public Meeting Transcript Available

FDA has released the transcript of its 9/16 public meeting that outlined the Prescription Drug User Fee Act Agreement for reauthorizing the program for fiscal years 2028 through 2032. Under the agreement, the agency is proposing new mechanisms to reduce complete response letters, improve sponsor communications and address manufacturing

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Talk to FDA Early About Foreign Clinical Data: Analysis

14 Observations on Houston Rx FDA-483

FDA Updates ICH Standard for Electronic Safety Reports

Drug User Fee Agreement Public Meeting Transcript Available