On Wednesday, April 4, 2018, Food and Drug Administration (FDA) Commissioner Scott Gottlieb spoke at the National Rx Drug Abuse and Heroin Summit. Gottlieb opened by comparing recent opioid deaths to those that happened at the peak of the AIDS epidemic in 1995. He started off discussing different strategiesthe FDA has pursued to address the challenges presented […]
Category Archives: FDA
02
Feb
Feb
On January 30, 2018, the United States Food and Drug Administration (FDA) finalized the “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.” The Blueprint includes educational messages for health care providers involved in the treatment and monitoring of patients with pain. It also […]
CME, FDA, Opioids, REMS
FDA ER-LA REMS Day 2 of the Drug Safety and Risk Management Advisory Committee
05
May
May
Day Two of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) was lively and full of debate and conversation. The day started out with comments from the FDA, followed by presentations by Joanna G. Katzman, MD, MSPH, of the […]
CME, FDA, Opioids
FDA ER-LA REMS Day One of Meeting of the Drug Safety and Risk Management Advisory Committee
04
May
May
The Food and Drug Administration (FDA) is hosting a two-day long Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The FDA is seeking comments from the […]
04
Mar
Mar
There is a ballooning interest in biosimilars and interchangeable products in the pharmaceutical industry, especially with the first biosimilar in the United States being approved in 2015. The Food and Drug Administration continues to review other marketing applications for proposed biosimilar products. The FDA has announced that they have developed a free, Continuing Education […]
15
Dec
Dec
For many years, we have written about the authority granted to the FDA from the 1997 Food and Drug Administration Amendments Act of 2007 which requires REMS (Risk Evaluation and Mitigation Strategy) from drug and biologics manufacturers for products to ensure that any serious risks are outweighed by its benefits. REMS requirements can impose special […]
Affordable Care Act, CME, CMS, FDA, Healthcare Reform, Physician Payment Sunshine Act
21st Century Cures Initiative Introduces Significant Legislative Proposal
28
Jan
Jan
In April 2014, Energy and Commerce Committee Chairman Fred Upton (R-MI) partnered with Rep. Diana DeGette (D-CO) to launch the 21st Century Cures initiative with an important goal: to accelerate the discovery, development, and delivery of new treatments and cures for patients. Over the course of nearly a year, patients, providers, innovators, regulators, and researchers […]
23
Jan
Jan
Recently, Douglas C. Throckmorton, MD, the Deputy Director for Regulatory Programs at FDA’s Center for Drug Evaluation and Research (CDER) gave a presentation titled, “Transforming Professional Medical Education: Role of FDA“. Dr. Throckmorton stated the opinions and information in the presentation are his own and do not necessarily reflect the views and policies of the […]
14
Nov
Nov
In May 2010, the Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) launched the Bad Ad program. This program was designed to raise awareness among health care professionals (HCPs) and HCP students about untruthful or misleading prescription drug promotion and provide them with an easy way to report it to FDA. Since […]
07
Aug
Aug
The Food and Drug Administration (FDA) held a meeting on July 25th and 26th, 2013, to discuss Risk Evaluation and Mitigation Strategies (REMS). The FDA posted information about the meeting, including FDA slide presentation, agenda, and further reading. We have covered this topic on many occasions. As part of the reauthorization of the Prescription Drug […]
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