A recent survey of asset managers, broker/dealers, alternative managers and wealth managers found that compliance is now a core business practice of financial services firms, yet many are not yet devoting the financial resources toward making these programs truly effective. Firms have been facing enhanced scrutiny for years: 81% of respondents stated that they are […]
Regulatory Compliance
Talk To The Hand: Pharma Wins Freedom Of Speech Case
In May, I wrote about how pharmaceutical companies were attempting to stop the FDA from banning the promotion of drugs for off-label uses. According to an Amarin press release issued on August 7, 2015, a United States District Court sided with the pharmaceutical company, saying that they “…may promote to healthcare professionals certain uses […]
What Kim Kardashian Taught Me About Pharma
In case you missed the headlines in the last few days, the FDA issued a Warning Letter to Duchesnay over Kim Kardashian’s Instagram post promoting Diclegis, the pharmaceutical company’s drug for “the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management,” commonly known as morning sickness.
Naming Drugs And Medical Devices Is An Art
Naming drugs and medical devices is an art form that requires creativity, knowledge of linguistics, and an understanding of how to navigate the regulatory landscape. It’s easy to think of names, but coming up with ones that are meaningful and memorable, yet different enough than anything currently on the market, is another story. The International […]
Analysis Finds Reporting Delays For Serious Adverse Events
According to a recent research letter in the Journal of the American Medical Association (JAMA), an analysis of serious adverse event (SAE) reports from January 1, 2004 and June 30, 2014 (with certain exclusions) concluded that drug companies were more likely to delay the reporting of such instances within the required 15 calendar days, if […]
Risk-Based Monitoring, In Layman’s Terms
One of my LinkedIn contacts shared the video Risk-Based Monitoring vs Remote Monitoring Finally Explained, in which Dan Sfera of www.theclinicaltrialsguru.com explains both concepts in layman’s terms. In essence, the idea of Risk-Based Monitoring (RBM) is to leverage the data in existing IT systems to spot, rectify, and prevent issues relating to the execution of […]
The Yellow Card You Can’t Argue With
You can’t argue with it because it’s a good idea. Yellow Cards have gone digital. Not the ones used in soccer/football, but the ones used in the UK for reporting adverse events. When governments undergo digital transformation, you know it’s not a fad. After all, they’re not typically early adopters…of anything. Last week, the […]
Finding All Relevant Documents When A Drug Has Many Names
Most of us “regular people” refer to pharmaceutical products by their trade name, but that’s not the case among life sciences professionals in research and development departments. In fact, during a product’s lifecycle, chances are it has been referred to by at least four names: a chemical compound, a company code, a generic name, […]
Ex-Medical Device CEO Sentenced For 2 Years
Wow, it’s not often you hear about executives from life sciences companies getting jail time. But in the case of the former CEO of OtisMed, that’s just what he got: two years and a small fine. The company also agreed to pay more than $80 million to resolve other charges. Without receiving FDA approval, […]
Argus Safety 8.0 Released! Reporting And Integration Heaven
Coinciding with the Drug Information Association’s (DIA) 51st Annual Meeting in Washington, D.C. last week, Oracle announced the newest version of its drug safety and pharmacovigilance system. Argus Safety 8.0, considered a major release, offers new features and functionality to help life sciences companies comply with ever-changing global regulatory requirements. The Standard Edition of […]
When The FDA Is Concerned About Your Ability To Monitor Drugs
A couple of weeks ago, I wrote about a warning letter that was issued to a pharmaceutical company last month. I highlighted one of the FDA’s findings, which had to do with the company’s standard operating procedures (SOPs) having an insufficient amount of detail about their process for collecting adverse events. Today, I want […]
Are Test User Accounts Subject To 21 CFR Part 11?
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Regarding user accounts: During the User Acceptance Testing (UAT) of a system, are these accounts regulated the same way or can ‘generic’ […]