E-Alerts
-
Pharma Company Receives Safety Warning Letter
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 [...]
-
Supreme Court Ruling on Generic Label Suits
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 [...]
-
J&J recall issues extend beyond consumer products to prescription medications
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 [...]
-
DIA Announces Webinar: What You Need to Know about FDA’s Drug Listing and Import Process
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
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 [...]
-
FDA Warns Pharmaceutical Company Regarding AE Reporting
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 [...]
-
FDA Reports Over 157,000 AE reports during Q1 2010
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.