FDA Pharmaceutical and Medical Device Books
Published: October 2010 | Pages: 276 | Price: $377 | ISBN: 978-1-60004-206-5
Despite years of harmonization talks, the EU and US still follow very different marketing approval processes for medical devices. And when the EU’s MDD went into effect in 2010, those differences became more pronounced. Failing to know the differences could critically handicap your time to market and ability to operate efficiently. Failing to comply with those differences could shut you out of EU markets completely.
Published: October 2010 | Pages: 648 | Price: $377 | ISBN: 978-1-60004-204-1
Do you prepare your medical device facility for an FDA inspection the same way you did last year — or even six months ago? If you do, you could be in big trouble. The rules of the game have changed and the FDA is cracking down harder than ever before … and it’s only going to get worse.
The FDA’s New Focus on Part 11: How to Prepare for the FDA’s Tough, New Electronic Records Inspections
Published: September 2010 | Pages: 60 | Price: $377 | ISBN: 978-1-60004-124-2
Drug manufacturers: Be careful what you wish for. For years, drugmakers have urged the FDA to revisit 21 CFR Part 11, which governs electronic records. Now the FDA has done so — and the industry faces new compliance burdens.
Published: September 2010 | Pages: 44 | Price: $377 | ISBN: 978-1-60004-200-3
If you're going to conduct clinical trials or sell drugs in the EU, the way you handle safety reporting will be essential to your success. But navigating EU pharmacovigilance requirements is a complex task that starts in the early stages of drug development and extends right through the drug's life, and it varies subtly from one member state to the next. The only sane way to approach these requirements is to incorporate them into your company's risk-management processes and procedures.
Published: September 2010 | Pages: 33 | Price: $377 | ISBN: 978-1-60004-126-6
Clinical trials operators — the FDA is drawing a bead on you. Since 2008, the agency has issued 52 warning letters to investigators, CROs, sponsors and IRBs — an astonishing 30% increase over previous levels.
Published: September 2010 | Pages: 125 | Price: $377 | ISBN: 978-1-60004-123-5
Clinical trial sponsors always wrestle with the same big challenge — how to maintain the quality and integrity of their clinical trials while pushing their products through the regulatory approvals process. But all too often, trials are delayed by costly errors that can be avoided. Here’s how top-performing sites avoid these pitfalls.
Published: August 2010 | Pages: 131 | Price: $377 | ISBN: 978-1-60004-198-3
Attention drug and device manufacturers — the new health reform law is about to turn your marketing world upside down. Under new rules, companies like yours must begin collecting data about payments to physicians. And that’s just the tip of the iceberg …
Published: July 2010 | Pages: 37 | Price: $377 | ISBN: 978-1-60004-118-1
Will the electronic Common Technical Document (eCTD) submission you design today see your drug smoothly through its entire life cycle? Chances are it won’t — unless you make the right decisions now about everything from naming rules to authorship controls. Here’s where to start:
Published: July 2010 | Pages: 280 | Price: $377 | ISBN: 978-1-60004-112-9
With Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS, you'll have the tools to create and maintain a CCDS that will withstand regulatory scrutiny, and you’ll avoid the unnecessary extra work that comes from assuming what’s the best way to write them.
Published: July 2010 | Pages: 38 | Price: $377 | ISBN: 978-1-60004-114-3
False data in clinical trials isn’t new. What is new is the aggressive role the FDA expects drug and device companies and CROs to play. Under a proposed rule, the FDA says clinical trial sponsors must be proactive in reporting data that is even possibly false. But while it’s clear that noncompliant sponsors will face harsh prosecution, it’s less clear exactly what to report, how … and when.
Published: June 2010 | Pages: 88 | Price: $377 | ISBN: 978-1-60004-110-5
Since 2009, warning letter citations make clear that it’s no longer enough for you to look back at the data and then react to quality problems. You are now expected to trend your quality data.
Published: March 2010 | Pages: 41 | Price: $377 | ISBN: 978-1-60004-106-8
Responding to FDA 483s spells out best practices for managing the post-inspection process so you don’t get callbacks from the FDA. Think of it as “483s for Dummies” — a plain-English step-by-step guide that goes beyond boilerplate advice and digs into specifics that help you fashion a top-quality response to your next Form 483.
Human Error Reduction: Techniques for Stronger CAPAs, Root Cause Analyses and Manufacturing Quality Improvement
Published: March 2010 | Pages: 33 | Price: $377 | ISBN: 978-1-60004-104-4
If you are involved in the manufacture of drugs or biologics, including contract manufacture — in quality, compliance or regulatory affairs — Human Error Reduction is a must-read report.
Published: March 2010 | Pages: 64 | Price: $377 | ISBN: 978-1-60004-096-2
It’s all in Managing Clinical Investigator Compliance, the soon-to-be-released management report from FDAnews that brings you up to speed on the latest requirements for investigators.