The US Food and Drug Administration (FDA) needs to take a more proactive approach in combatting misinformation and communicating decisions to the public when approving drugs, especially when the decision goes against the recommendations of its advisory committees. Not doing so will continue to undermine the public’s trust in the agency, said a panel of former FDA commissioners and others at the Food and Drug Law Institute (FDLI) annual conference on Tuesday.   Califf ad...

Regulatory intelligence activities are complicated by the push for stronger product sales in emerging markets, where medical device regulations can change rapidly or be confusing and even contradictory. Understanding how, when, and with whom to communicate the new or changing regulatory information within a medical device company affects global market strategy and product success. The research reported here examined how medical device companies structure their regulatory i...

The ability to confidently convey an idea and persuade others of its benefits to your organization is key to achieving success. This article discusses ways to use persuasive skills, the importance of physical presence, and tips for maintaining a positive attitude.   Introduction How often does a decision maker or specifically, your manager, reject your ideas? Have you ever wondered why co-workers with inferior proposals have their requests approved? You are convinc...

Strong written communication skills are invaluable, even in a profession in which writing is not a key component. Good writing can be used as a tool to impart information or convince colleagues to pursue a particular course of action. It can also be a means of demonstrating one’s creative and strategic thinking. In short, investing time in learning and refining strong writing skills is a crucial element of career advancement.   This article will provide tools and techn...

In this article, the author discusses the importance of soft skills training during the COVID-19 pandemic in the context of their role in defining one’s employability and advancing both personal and team success in achieving goals. These training sessions will give employees an opportunity to connect virtually with their colleagues, improve morale, and provide skills that will increase productivity and create a more positive working environment. The article provides tools ...

The global pandemic has created many challenges this year for regulatory professionals, especially in the way it has transformed workplace interaction and communication. This article provides some helpful tips on video conferencing, phone calls, active listening, and trending business applications as a way of sharpening communication skills and improving business and regulatory interactions.   Introduction Regulatory affairs (RA) can be structured differently across ...

This article discusses the critical need for clear, precise, and consistent communication on the part of regulatory professionals in interactions and submissions with health authorities. It presents various approaches and offers examples for the regulatory professional to draw on to improve the clarity of such communications.   Introduction As a regulatory professional, one is constantly reaching for and achieving new goals. Whether it is initiation of a first-in-hum...

Hundreds of thousands of units of Medtronic implantable cardiac devices, programmers and home monitors are vulnerable to cybersecurity incidents, according to two US federal government notices. On Thursday, the US Food and Drug Administration (FDA) issued an FDA safety communication, while the US Department of Homeland Security's (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory to flag cybersecurity vulnerabilities detected in...

Patients and health care providers should know that the safety and effectiveness of robotically-assisted surgical devices for the prevention or treatment of cancer has not been established for use in the US, a US Food and Drug Administration (FDA) safety communication warned on Thursday. The safety communication urges caution when using robotically-assisted surgical devices for mastectomy and any other cancer-related surgery, citing the lack of FDA evaluation on use of ...

The US Food and Drug Administration (FDA) on Wednesday warned physicians against using implantable pumps to deliver pain medications directly into patients’ spinal fluid with drugs they were not approved for use with.   Using drugs that have not been approved for compatibility with the pumps could lead to dosing errors, pump failure, opioid withdrawal, infection, fever, vomiting, muscle spasms, cognitive changes and cardiac or respiratory distress, FDA says.   “The...

This article focuses on the US Food and Drug Administration's (FDA's) draft guidance as it impacts prescription drug promotion and offers examples regarding information considered consistent with labeling. It emphasizes the need for regulatory professionals to better understand and adhere to FDA's evidentiary standards by utilizing examples of the Office of Prescription Drug Promotion (OPDP), formerly Division of Drug Marketing and Communications, enforcement actions tha...

The US Food and Drug Administration (FDA) on Thursday issued a warning to healthcare providers over serious adverse events tied to programmable syringe pumps when set to deliver drugs at lower volumes, especially for infants and critically ill patients. In response, FDA has provided manufacturers of the devices with new language to add to their instructions for use that includes a list of warnings and considerations to mitigate the risks. The agency also says that ...