DDN Medical Affairs

Pharma Company Receives Safety Warning Letter

corecreative — Tue, 25 Oct 2011 21:54:33 +0000

The FDA recently published a Warning Letter to a pharmaceutical company citing its “failure to develop adequate written procedures for surveillance, receipt, evaluation and reporting of post-marketing adverse drug experiences (ADE) to FDA.”

All New Drug Application (NDA) holders are required to have written procedures to detect, correctly identify, assess and report ADEs to the FDA. One of the failures to do so in this case was linked to a lack of communication between business partners.

DDN Medical Affairs has extensive experience in communicating with multiple partners on behalf of our clients to provide compliance with the regulations and mandatory timelines for AE reporting.

Contact Us to learn more about ways in which DDN Medical Affairs can partner with you to meet your regulatory obligations.

Supreme Court Ruling on Generic Label Suits

ehecht — Tue, 28 Jun 2011 14:03:12 +0000

On Thursday, June 23 the US Supreme Court ruled that generic drug manufacturers could not be sued under state law for failure to warn patients regarding a drug’s side effects provided that their product label is identical to the reference listed drug’s label. The decision was based upon federal law requiring generic labels to match RLD labels pre-empting state law requiring strengthening of labels as manufacturers become aware of new risks.

J&J recall issues extend beyond consumer products to prescription medications

corecreative — Mon, 27 Jun 2011 15:31:50 +0000

Johnson and Johnson has been beset over the past two years with recalls of consumer medicines, prescription drugs and medical devices. The latest two recalls stem from odors believed caused by trace amounts of a chemical called TBA found in pallets used to transport and store materials. A small number of patients may experience certain gastrointestinal symptoms. Such adverse events may be avoided by closer management of supply chain issues.

click here to read the full article from Reuters

DIA Announces Webinar: What You Need to Know about FDA’s Drug Listing and Import Process

corecreative — Mon, 27 Jun 2011 15:31:21 +0000

Two-part Webinar Series begins July 13

Unique opportunity to hear FDA explain the nuances of the eDRL process as it relates to human and veterinary products.

Part 1- Webinar Drug Listing/Regulatory Perspective

Part 2- Importation Perspective

New business focus on Adverse Event reports

corecreative — Tue, 29 Mar 2011 14:31:20 +0000

On Tuesday, the Supreme Court ruled unanimously that investors could sue a pharmaceutical company for not disclosing reports of adverse events for an over-the-counter cold product.

This decision will likely affect the way in which companies view reports of adverse events and the importance of making that information available not only to the medical community but also to other stakeholders with an interest in the product.

More information can be found at Bloomberg.com

FDA Warns Pharmaceutical Company Regarding AE Reporting

corecreative — Mon, 28 Feb 2011 14:32:46 +0000

The FDA recently published a warning letter, dated January 28, 2011, which was sent to a major pharmaceutical company with regard to their adverse event reporting practices.

In addition to a number of late 15-day adverse event reports, the warning letter also addressed the following concerns:
1) inadequate written procedures (SOPs) for surveillance, receipt, and reporting of adverse events,
2) failure to include all post-marketing studies in the Annual Report to FDA,
3) apparent incomplete validation of the adverse event reporting system resulting in inaccurate data migration and potential reporting errors.

To see the warning letter please click on this link: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm243585.htm.

FDA Reports Over 157,000 AE reports during Q1 2010

corecreative — Thu, 04 Nov 2010 22:03:08 +0000

Drug Safety is currently a very important topic. On November 4, FDA reported that it had received over 157,000 Adverse Event reports during the first quarter of 2010. Of these reports, over 91,000 were expedited 15-day reports. Expedited reports are required for serious and unlisted adverse events reported for marketed drugs.