FDA Related News

Most Common 2022 BIMO Violations

Three Goodwin attorneys analyze the results of BIMO inspections in 2022 and the beginning of 2023, listing most common violations.

Federal Register

Consumer Groups Sought for Advisory Panels

Federal Register notice: FDA asks that consumer organizations notify the agency if they are interested in participating in selecting voting and nonvot...

Federal Register

Guide on Metabolism Inborn Errors

Federal Register notice: FDA makes available a revised draft guidance entitled Inborn Errors of Metabolism That Use Dietary Management: Considerations...

Human Drugs

BeiGene sNDA for Brukinsa in Lymphoma

FDA accepts a BeiGene supplemental NDA for Brukinsa (zanubrutinib) in combination with obinutuzumab for treating adult patients with relapsed or refra...

Federal Register

Panel to Discuss Decongestant Phenylephrine

Federal Register notice: FDA announces a 9/11-12 Nonprescription Drugs Advisory Committee meeting to discuss decongestant phenylephrine.

Human Drugs

Lymphoma Trial Enrollment Paused After 7 Deaths

ADC Therapeutics pauses new patient enrollment in the Phase 2 LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-lpyl) and rituximab i...

Human Drugs

Praise for FDA Final PFDD Guidance

Three stakeholders praise an FDA guidance on adding clinical outcome assessments to patient-focused drug development regulatory decision-making and su...

Medical Devices

Megadyne Recalls MEGA Patient Electrodes

Megadyne recalls its MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes after receiving burn reports affecting pediatric and adult patients.

Human Drugs

Innovative Manufacturing Workshop Positive Comments

Two stakeholders respond positively to a recent FDA workshop on innovative drug manufacturing techniques.

Medical Devices

No Higher Death Risk in Paclitaxel-Coated Devices: FDA

FDA says it no longer sees the potential for excess mortality in paclitaxel-coated devices used to treat peripheral arterial disease.