New or revised terms include:

• adverse drug experience
• new safety information
• study*
• clinical trial*
• Postmarket safety activities
• Establishment (for medical devices)

Here are the definitions of each I was able to discern from various components of the statute:

Adverse Drug Experience:  Any adverse event associated with the use of a drug in humans, whether or not the event is considered drug related.  This includes pharmacological action failure, withdrawal adverse events, drug abuse adverse events, overdose adverse events, or an adverse event occurring during the course of professional treatment using the drug.

New Safety Information:  Information derived from a clinical trial, adverse event report, postapproval study, peer-reviewed biomedical literature, data derived from postmarket risk and analysis, or other scientific data deemed appropriate by the FDA regarding serious risks (or unexpected serious risks) or the effectiveness of a risk evaluation and mitigation strategy since the medicine was approved.

Study:  Includes nonclinical tests, evaluations, etc. AND clinical trials.

Trial:  Only refers to tests, evaluations, etc. conducted on humans.

    *(Key point: the terms study and trial are no longer completely interchangeable.)

Postmarket Safety Activities:  Includes collecting, developing, and reviewing safety information on approved drugs, including adverse event reports, as well as developing and using improved analytical tools to assess potential safety problem, including accessing external databases.

Establishment:  Includes the manufacturer of a device, a sterilizer, a contract manufacturer, a single-use device reprocessor, or a specification developer that either markets or distributes the device or that arranges for the manufacture of devices through a contract manufacturer.

FDA has placed some of these definitions in its draft guidance on enforcing Section 505(o), see page 15.

If you have suggestions or improvements, please comment below.

• Challenges in Choosing an Auditor
• Designing a Records Management Training Program
• Drug and Biotech Warning Letter Trends
• Three Threshold Part 11 and Record Archiving Questions
• Managing Project Risk Proactively
• Featured Reading:  The Imposter

Downloads for subscribers include:

• EMA Site Master File guidance
• FDA guidance on using bayesian statistics in clinical trials
• FDA guidance on proprietary drug name submissions
• FDA guidance on cGMP dissolution calibration
• Article on reimbursement considerations for device firms in preclinical
• Article on 28 points to consider to protect clinical trial patient privacy

Also, don't forget - if you pre-order a copy of my new book, Get to Market Now!  Turn FDA Compliance into a Competitive Edge, you can save 32% at Barnes & Noble.  The book will be on bookstore shelves on May 1.

You can see my article here:

http://www.contractpharma.com/expertsopinion/2010/02/12/cmos_and_complete_response_letters

In summary, it's been my experience that firms really have two choices, neither of which is particularly easy or 100% perfect:

1.       Write a contract that specifically spells out how your CMO is to retain records, what records it is to retain, what oversight and reviews of records your CMO is to conduct, by whom, how often, and so on – in other words, require in the contract that the CMO implement all the aspects of what you believe go into a good records retention program for FDA compliance – and then audit that regularly with dedicated records review due diligence; OR

2.       Expect your CMO to already have an FDA-compliant records management program in place and conduct your on-site due diligence and quality system audits to verify compliance with this as it relates to records relevant to your product and company.

You can get some good advice along with insights into building your own FDA records control programs by taking a look at my recorded seminar on records retention and management for FDA compliance.  If you need outside help, consider my private FDA records consulting service.

When it comes to managing critical suppliers' records, if you've got a more ideas than the two I've listed above, I'd love to hear it.  Just bear in mind - coming up with good compliance ideas is easy; coming up with enforceable good compliance ideas is definitely a bit more challenging.

You can save about $20 pre-ordering it now through the above link to Barnes & Noble.  As soon as the pre-order is available through Amazon.com, I'll post that as well.

And the dedicated book website will be available to everyone in May with the book's publication; current subscribers to my FDA newsletter SmarterCompliance will get earlier access to all the templates and downloads.

For now, if you've any questions, please feel free to let me know!

Some points from the article:

• The sooner you can evaluate reimbursement potential, the better your return on investment in clinical trials
• Try to build a reimbursement evaluation into the stage gate review process for moving a new medicine from preclinical to clinical
• Early reimbursement evaluation allows you to determine what potential customers (prospective patients, physicians, hospital administrators, etc.) will need to see when it comes to efficacy and safety claims
• Early reimbursement evaluation gives you the time to better shape your marketing messages to different customers
• Early reimbursement offers you the chance to set better cost controls for production and the rest of development; it will hardly benefit you as the company if you are making a product that costs you more than you will earn back in reimbursement

Key tactics to help incorporate reimbursement planning early in development include stage gates, regulatory affairs road-mapping, and clinical regulatory strategic plans, all of which I discuss in detail in my forthcoming book, Get to Market Now!

Bringing in reimbursement considerations as early as possible in development help demonstrate an integrated, holistic compliance and development strategy - and show how compliance departments such as regulatory affairs and quality management drive value to a company's bottom line.  And that's what I call Lean Compliance.

Are you ready?

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In my book, Get to Market Now (slated for a May 2010 publication through Logos Press), I argue that firms can be making much better use of the preclinical stage through techniques such as:

• Crafting a clinical regulatory integrated strategic plan
• Bookshelving of previous studies into large databases
• Mining the data of those databases as part of an extended literature survey
• Capturing the voice of the customer (e.g., physicians, prospective patients, etc.)
• Summarizing preclinical studies to include potential critical product quality attributes (CQAs) and a risk analysis
• Planning and undertaking Phase 0 feasibility studies

Charles River has a good six months to put in place a strategy that incorporates tactics just like these, and offering them to clients (something that will save their clients money and time as well).  If your firm already has a number of preclinical studies underway - or planned - consider any of these tactics to help you improve R&D productivity and speed time to market.  Recent FDA and ICH guidelines encourage the adopting of many of these tactics through the quality by design philosophy.  Firms that ignore all the new product development options available to them in the 21^st century in the preclinical stage risk staying back at the 1 in 250 success rate of the 20^th century’s preclinical stage.

If you’d like to learn more about these tactics and adopting them into your preclinical development efforts, contact me through my firm.

Have a different opinion?  Share it.

Three tips to elevate your communications when it comes to regulatory compliance and quality systems:

1. Equate email with image.  Think of email as tiny bits of a virtual company image.  At a minimum, use spell check (but don't rely solely upon it), keep the number of recipients to a minimum, do not flag items as urgent or high priority if they really aren't, and understand that email is not private.  As a colleague once put it in a training session, "Don't put anything in your email that your mother would be ashamed of reading in tomorrow's New York Times."
2. Readability of memos and emails.  When it comes to memos, use your word processing program to check for the ease of comprehension (e.g., readability).  Microsoft Word, for instance, will allow you to check readability levels when you check spelling and grammar.  But when it comes to emails, you'll need to do the work, so some rules to keep in mind:  anything more than 3 paragraphs will encourage skimming so be cautious; when you can, number items rather than bullet point them; keep lists to under 5 items; and make sure to read through any email to a regulatory agency or your boss (at minimum) to ensure you've not inadvertently left out a word or two (something we're all guilty of occasionally).
3. Visit in person.  Know when to write, call, or visit.  If you're having trouble picking just the right words or phrases to use to avoid misunderstandings, that's the signal to step away from the computer and go talk to someone in person or on the phone.

The news is full of pharmaceutical and device firms who've gotten sued or otherwise involved in litigation, and have been forced to divulge their emails and internal business communications.  Don't join in.  Use these tips to help you think twice about recording comments and phrases that might later be taken out of context and used to portray you or your company in a negative, uncaring light.

For more advice you can use on controlling records and handling requests from FDA for records or emails, see my recorded seminar, FDA Quality Systems Records Requirements and Retention for Pharmaceutical, Biotech, and Device Firms - GLPs, GCPs, GMPs, QSRs.  You get a 9-page matrix detailing out various retention requirements under each regulation along with loads of tips and advice on how to build in retaining the right records to prove compliance and product safety, efficacy, and quality.

And if you need more advice, feel free to contact me directly.

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