| Subject: | FDA Announces Revisions to Coumadin (warfarin sodium) Labeling and Issues a New Patient Medication Guide; FDA Issues Notice on Updates to iPLEDGE Program for Accutane (Isotretinoin) |
| Category: | Food and Drug Administration (FDA)
|
| Published: | Tue, 10 Oct 2006 - 12:00 am |
| FDA Announces Revisions to Coumadin (warfarin sodium) Labeling and Issues a New Patient Medication Guide
Audience: Pharmacists, other healthcare professionals, and patients
The FDA and Bristol-Myers Squibb have notified pharmacists and physicians of revisions to the labeling for Coumadin, to include a new patient Medication Guide as well as a re-organization and highlighting of the current safety information to better inform providers and patients.
The FDA regulation 21CFR 208 requires a... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
|
REFERENCES:
External Links:
|
|
StayAlert!® Virtual Compliance Administrator™ keeps clients informed by email of any changes to Federal regulations, including Joint Commission (TJC, formerly JCAHO), CDC, CMS, DHHS, FDA, OSHA, OIG, and many more, and also provides downloadable tools to ensure compliance. StayAlert! is a premium product sold as an annual site-license subscription. With the site license, the client can sign up an unlimited number of users for the email alerts and access to the StayAlert! online regulatory library. Other vendors have components of legislated requirements available online or on CD-ROM. However there is no other product that marries regulatory agency mandates with implementation tools, making the latest compliance information immediately available online. No other product provides an interpretative analysis, followed by a practical application tool, therefore providing users with an immediate solution to compliance problems. StayAlert! includes operational components for healthcare organizations, allowing complete facility compliance with mandated requirements, online. |
|
