by Tess Chadwick | Oct 8, 2012 | REMS
Introduction As part of an effort to address the abuse and misuse of prescription drugs, the US Food and Drug Administration (FDA) approved in July 2012 a risk evaluation and mitigation strategy (REMS) for extended release (ER) and long-acting (LA) opioid analgesics.... by Ankita Kunadia | Oct 8, 2012 | REMS, Safety
Introduction Section 505-1 of the Food and Drug Administration Amendments Act (FDAAA) allows the FDA to require a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of a drug outweigh the risks. Recent news regarding REMS and the manipulation... by Eileen | Oct 4, 2012 | Guidances, REMS, Submissions
Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications Status: Draft Date: September 2009 Target Audience: Industry sponsors and applicants Laws Referenced: Section 505-1 of the Federal Food,... by Darshan Kulkarni | Apr 12, 2012 | FDA, Guidances, REMS
Introduction The FDA’s job is to protect the public health by ensuring the safety, effectiveness, and security of biological products, devices, foods, cosmetics, dietary supplements, and certain products that give out radiation. To accomplish this mission, the FDA... by Tracey | Feb 14, 2010 | Guidances, Pharmacovigilence, REMS, Submissions
Industry Development and Use of Risk Minimization Action Plans (RiskMAP) Status: Final Date: March 2005 Target Audience: Sponsors, usually a pharmaceutical company who develops prescription drugs, including biological drug products Laws and Regulations: Protection of... by Jennifer Han | Feb 10, 2010 | Guidances, Pharmacovigilence, REMS, Safety, Submissions
Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification on What to Report Status: Final Date: August 1997 Target Audience: Industry required to report adverse experiences to the FDA, including: Applicants of approved...
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