FDA News

Sec. 820.80: Acceptance Activities
The Device Industry’s Silent Problem
An FDAnews Webinar Read More
Tenth Annual Medical Device Quality Congress
From Risk Management to Postmarket Surveillance
Bethesda, MD Read More
Dietary Supplement GMP Inspectional Readiness:
A Comprehensive Road Map To 21 CFR 111
An FDAnews Virtual Conference Read More
More Events

Report Points to Steep Four-Year Rise in Device Warning Letters

The FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds.Read More

Analyst: New Hospira Warning Raises Questions on Quality Culture

A new warning letter to Hospira’s Lake Forest, Ill., facility cites 12 findings related to its infusion pump manufacturing.Read More

‘Significant Decision’ Clarified in CDRH Appeals Guidances

CDRH recently released two guidances aimed at clarifying the center’s appeals process and bringing it in line with last summer’s FDA Safety & Innovation Act.Read More

FDA to Hold Two-Day Public Meeting on REMS Challenges

The FDA plans to hold a two-day public meeting in July on the challenges of standardizing and assessing risk evaluation and mitigation strategies (REMS) for drug and biological products — part of a commitment the agency made to drugmakers under the most recent user-fee agreement.Read More

Resource Center

Tenth Annual Medical Device Quality Congress
From Risk Management to Postmarket Surveillance
Come for this valuable opportunity to hear FDA officials discuss regulatory plans and objectives — and ask questions you need answered; learn from device industry experts, consultants and other experts with actionable tips and strategies you can take straight back to the office; and network with other professionals who understand your challenges; share war stories and insights over a drink. Register Today. Read More
Conducting Bulletproof CAPA Investigations — ADVANCED
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations and Understanding the Root Cause
The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today. Read More
Surviving an FDA Inspection
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not! Read More

Report Points to Steep Four-Year Rise in Device Warning Letters

Analyst: New Hospira Warning Raises Questions on Quality Culture

‘Significant Decision’ Clarified in CDRH Appeals Guidances

FDA to Hold Two-Day Public Meeting on REMS Challenges

Novartis Gets 483 for Batch Quality Control Process Flaws

Experts: Use Traditional Marketing as a Guide for Social Media Policy

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