The Urgency of PDUFA
Thousands of Americans could die waiting for the FDA to approve new, lifesaving treatments if Congress fails to reauthorize a 25-year old law this summer. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 20, 2017 Category: Pharmaceuticals Source Type: blogs
The Maine Event
Maine lawmakers are advancing LD 1280, a bill that seeks to reduce patients' health care bills by speeding up the introduction of low-cost generic drugs. The bill has a noble goal. But it is terribly written (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 19, 2017 Category: Pharmaceuticals Source Type: blogs
Gottlieb talks tech
n a blog post Thursday, FDA Commissioner Scott Gottlieb outlined regulatory steps designed to promote development of digital health technologies. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 16, 2017 Category: Pharmaceuticals Source Type: blogs
Improving Patient Advocacy Across the Globe
If you’re interested in the FDA’s Patient-Focused Drug Development program and attending next week’s BIO bash, hope you can attend (and participate) at this interactive panel discussion -- Improving Patient Advocacy Across the Globe. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 14, 2017 Category: Pharmaceuticals Source Type: blogs
Wired Magazine Article Celebrates The New Eugenics
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 14, 2017 Category: Pharmaceuticals Source Type: blogs
Regenerative Medicine Can Revitalize America!
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 12, 2017 Category: Pharmaceuticals Source Type: blogs
Regulatory Learnings from the Real World
In March, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSARM). voted 18-8 that Opana ER’s benefits do not outweigh its risks. And on June 8th, the other shoe dropped. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 12, 2017 Category: Pharmaceuticals Source Type: blogs
FDA, JAMA, PV, RWE and other relevant acronyms
Nearly one third of drugs newly approved by the US Food and Drug Administration (FDA) are affected by safety issues that were not known at the time of approval, a study has shown. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - May 9, 2017 Category: Pharmaceuticals Source Type: blogs
BCBSA BS on Rx
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - May 9, 2017 Category: Pharmaceuticals Source Type: blogs
ICER’s GIGO
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - May 5, 2017 Category: Pharmaceuticals Source Type: blogs
PV in the EU: Can the Doctor See You Now?
European, national, and regional authorities should invest in awareness-raising campaigns to increase public knowledge about medicinal safety and adverse drug reaction (ADR) reporting. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 6, 2017 Category: Pharmaceuticals Source Type: blogs
Scott STAT!
“I think Scott is very much for good regulation, and very much against bad regulation,” Pitts said. “Importantly, he recognizes where FDA core mission stops, and where mission creep begins — and that’s an important finesse he’d bring to the commissioner’s chair.” (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 6, 2017 Category: Pharmaceuticals Source Type: blogs
ICER Devalues People With Rheumatoid Arthritis
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - March 29, 2017 Category: Pharmaceuticals Source Type: blogs
Fake DTC news mustn't drive the healthcare debate
When pundits, politicians, and policymakers speak about “sales and marketing,” the picture they are painting is of direct-to-consumer pharmaceutical advertising – the public face of Big Pharma. So, let’s set the record straight on that straight away. In 2016 $5.6 billion was spent on DTC. Same period R&D spending is roughly $70 billion. Amorous middle-aged couples in claw foot bathtubs are a lot sexier than excel spreadsheets, but facts as pesky things. Surprised? (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - March 27, 2017 Category: Pharmaceuticals Source Type: blogs
Fighting Opioid Abuse with Regulatory Clarity
At the recent abuse deterrent opioids summit, CDER Deputy Director for Regulatory Programs Dr. Doug Throckmorton presented the FDA ’s position. He said, “We must move on from older to newer technologies. Amen. But how? (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - March 14, 2017 Category: Pharmaceuticals Source Type: blogs
