Electronic Drug Registration and Listing Instructions

Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments’ Report of Private Label Distributors).

Beginning June 1, 2009, FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. Moving from a paper-based format to an electronic system will improve the timeliness and accuracy of the submissions.

To submit drug establishment registration and drug listing electronically:

* Go to: Electronic Submissions Gateway and obtain an gateway account.
* Go to: D & B website and request a DUNS number.
* Prepare the SPL. For more information you can go to the Structured Product Labeling Resources website.
* Send your SPL through the Gateway to the OC center.

Source: FDA

FDA warning letter or recall?

Some Facts

1. Of the 74 warning letters issued in 2007 32% contained citations with respect to improper or ineffective process validation.
2. Recalls resulting from improper or ineffective process validation has resulted in millions of dollars losses and significant drops in company share prices.
3. Ineffective process validation has resulted in the release of products that have caused severe harm or injury to end-users.
4. Process Validation problems have resulted in consent decrees and fines in the hundreds of millions of dollars.
5. Foreign manufacturers have been banned from importing their products into the United States when cited for process validation non-compliance.

FDA Recalls seem to be increasing which means that the FDA not only remains just as active, but may be taking stronger action now than ever before http://www.fda.gov/

References:

1. AAMI
2. www.complianceonline.com

Ranbaxy recalls drug from US market

Pharma major Ranbaxy Laboratories today said its US-based subsidiary, Ranbaxy Laboratories Inc Priceton NJ, was recalling capsules used in the treatment of acne (a type of skin disease) from the US market.

What it Recalled?

Ranbaxy Laboratories Inc Priceton NJ is conducting a voluntary recall of Sotret Isotretinoin capsules, USP 40 mg, which is limited to Lot No 1876849, currently available in the US market.

Source: Business Standard

Federal Trade Commission: August 1, 2009 Deadline

The Federal Trade Commission (FTC) approaching its deadline of Identity Theft Red Flags Rule on August 1, 2009.

What Rule requires

1. The Rule requires creditors and financial institutions to adopt identity theft prevention programs.

2. Purpose of the Rule dictate that health care professionals are covered by the Rule when they regularly defer payment for goods or services

The FTC is also concerned with Medical identity theft, where a patient uses the name or insurance information of another person. Medical identity theft can result in false billing and potentially life-threatening corruption of a patient’s medical records.

Why is compliance with the Red Flags Rule important?

The Red Flags Rule is essential to healthcare’s moving ahead and becoming fully operational in an E-Health environment.

Protecting against identity theft/medical identity theft and ensuring data confidentiality, integrity, and availability are critical success factors in the “trust” equation essential to E-Health.”

The FTC offers a “how-to” guide for businesses on the Rule, available at:
http://www.ftc.gov/bcp/edu/pubs/business/idtheft/bus23.pdf and a do-it-yourself kit for low-risk businesses available at: http://ftc.gov/bcp/edu/microsites/redflagsrule/RedFlags_forLowRiskBusinesses.pdf

Source: FTC.gov Dotmed

EMEA: Application Process for Pediatric Product Investigations

European Medicines Agency (EMEA) has issued a clarification of the application process for pediatric investigation plans (PIPs) in the form of a question-and-answer document posted on the agency’s website last month.

Click here to view

The document explains  the information drugmakers should submit to the EMEA and how and when it should be submitted.

FDA : Black Box Warning

Is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects.

A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.

The U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires.[2]

Source: Wikipedia

Anti-Smoking Drugs Get FDA ‘Black-Box’ Warning

The U.S. Food and Drug Administration said it was mandating the black-box warnings, the strictest possible, based on reports to the agency of these side effects and on a review of clinical trials and scientific literature.

Source: Drugs.com

Leading portals for Online Compliance training

Compliance / Regulatory professionals are opting for more Online mode of training rather than attending physical conference, through Web Seminars, recorded webinars from the Industry expert.

Here are the few leading portals – www.wecomply.com | www.complianceonline.com | http://www.hipaarx.net/ | www.elementk.com | www.hrclassroom.com | www.csregs.com |these are  Online training center for all compliance & regulatory professionals around the world.

These types of portals try to bridge the gap between the knowledge seekers & providers by bringing both of the communities on a same platform with increased access to all information needed for Individuals & organizations to be compliant with rules & regulations.

Electronic Medical Device Reporting (eMDR)

Collection of adverse event information on medical devices is mandated by Medical Device Reporting (MDR) requirements of the Food Drug and Cosmetics Act (FD&C Act) (21 USC 360i), and comes primarily from manufacturers, user facilities, importers and voluntary reporters.

The electronic Medical Device Reporting (eMDR) project provides the capability for electronic data entry and processing of medical device adverse event reports.

The eMDR application accepts electronic medical device reports via two options, designed for low and high volume reporters. Both options are open to all reporters.

(1) FDA eSubmitter – a free downloadable application that will allow submission of MDR reports one at a time.

(2) Health Level 7 (HL7) Individual Case Safety Report (ICSR) – This option provides the capability to receive and process electronic MDR files either individually or as a batch and is particularly suitable for high volume reporters.

Source: FDA

FDA eSubmitter

The Food and Drug Administration’s eSubmitter tool is part of an electronic submissions program that originated in the Center for Devices and Radiological Health (CDRH).

FDA eSubmitter is an improved and expanded package for a variety of submission types and is now available for voluntary use by the sponsors and manufacturers in the device and Radiological Health and blood regulated industries.

eSubmitter is free software intended to allow sponsors to:

• electronically complete and submit premarket notification applications [510(k)] to the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
• electronically complete and submit information for a variety of radiation safety Product Reports and Annual Reports for radiation emitting products to the Radiological Health Program
• electronically complete and submit the Medwatch 3500A form for medical device adverse event reports
• electronically complete and submit form 2579 for Report of Assembly of a Diagnostic X-Ray Systems
• electronically submit blood related BLA’s as an approved participant in the FDA eSubmitter pilot evaluation program for the Office of Blood Research and Review (OBRR) within the Center for Biologics Evaluation and Research (CBER). See more information on becoming a pilot participant for CBER.

Download Software

To download the FDA eSubmitter software, click on the following link.

Way to Install

Save the installation zip file to your computer and extract the jinstall.exe file. Double-click the jinstall.exe file to run the installation. Follow the instructions provided in the installation wizard.

1. Download eSubmitter Software

2. Download User Manual (Updated June 2009)

3. Download Quick Guide (Updated June 2009)