Supplementing DSHEA
Very important initiative from the FDA to update DSHEA – without even once mentioning CBD oil. If you don't think the agency takes the twin issues of quality and claims seriously -- think again. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 11, 2019 Category: Pharmaceuticals Source Type: blogs
Greedy Tort Bar Tarts Up the CREATES Act
When members of the tort bar start to salivate over a piece of legislation, it ’s worthwhile to find out where the red meat resides. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 7, 2019 Category: Pharmaceuticals Source Type: blogs
Separating the Healthcare Wheat from the Political Chaff
Last night during his State of the Union, the President addressed the issue of drug costs. Some of the ideas are sound while others deserve, shall we say, more careful consideration. Let ’s look at the record. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 6, 2019 Category: Pharmaceuticals Source Type: blogs
AI? Aye. Aye.
FDA is enhancing its ability to handle real-world evidence by training reviewers in data science via a curriculum on machine learning and artificial intelligence, said FDA Commissioner Scott Gottlieb. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - February 4, 2019 Category: Pharmaceuticals Source Type: blogs
David Mitchell's Misleading and Deceptive Attack on Celgene
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - August 8, 2017 Category: Pharmaceuticals Source Type: blogs
PBMs Perpetuate EpiPen Formulary Monoply To Maximize Rebates
It's all about the money (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - August 7, 2017 Category: Pharmaceuticals Source Type: blogs
PBMs are worsening the opioid epidemic
When it comes to the US opioid epidemic, one overlooked culprit comes straight from our healthcare system: pharmacy benefit managers (PBMs). To improve their bottom line, they're blocking access to prescriptions that can help prevent overdoses. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - August 3, 2017 Category: Pharmaceuticals Source Type: blogs
Celgene CEO on CNBC: Getting patients access to 'precision' medicines is crucial
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - August 3, 2017 Category: Pharmaceuticals Source Type: blogs
Celgene CEO Plans to Deliver Personalized Medicine Directly To Patients
Bypassing middlemen to save lives faster. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - August 3, 2017 Category: Pharmaceuticals Source Type: blogs
Expanded Access App-ens
The Reagan-Udall Foundation has released an online tool to help patients and doctors find drugs that quality for the FDA program called expanded access, or compassionate use. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - July 25, 2017 Category: Pharmaceuticals Source Type: blogs
Wood to White Oak. The Rebirth of an Off-Label Debate?
Former Sidley Austin partner and product liability specialist Rebecca Wood has been named FDA chief legal counsel. Wood represented multiple life science clients during her nearly 17 years at Sidley, and notably penned briefs in two highly watched U.S. Supreme Court product liability/federal preemption cases, Warner-Lambert v. Kent, Riegel v. Medtronic, Inc . and Wyeth v. Levine. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - July 19, 2017 Category: Pharmaceuticals Source Type: blogs
Make PBMs Disappear, Not Just Transparent
Instead of making PBMs transparent we need to make them disappear. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - July 14, 2017 Category: Pharmaceuticals Source Type: blogs
Abuse-Deterrent Opioids and the Post-Approval Valley of Death
Although 10 new opioid products with abuse-deterrent formulations (ADF) have received regulatory approval in the United States, lack of willingness by insurers to reimburse patients for their use is seen as a primary challenge limiting ADF uptake, according to the Tufts Center for the Study of Drug Development. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - July 14, 2017 Category: Pharmaceuticals Source Type: blogs
ICER To "Prioritize" What Medicines Veterans Get
(Source: drugwonks.com Blog)
Source: drugwonks.com Blog - July 12, 2017 Category: Pharmaceuticals Source Type: blogs
Cutting through the (Us)din
What a great combination – Steve Usdin interviews Scott Gottlieb. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - June 26, 2017 Category: Pharmaceuticals Source Type: blogs
