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On Wednesday, August 1st, FDA released a notice with updated prescription drug user fee rates for fiscal year 2019. Prescription Drug Application Fees According to the Food, Drug, & Cosmetic (FD&C)...
Quality & Compliance
According to recent FDA updates on the implementation of the Safety and Innovation Act (FDASIA), nearly 40 percent of finished drugs are being imported, and nearly 80 percent of active ingredients,...
Data collection and analysis is expensive and has the potential to compromise a company’s hard-won compliance position. It is therefore critical that technical leaders follow a systematic and proven...
Pharmacovigilance
On March 20, 2018, the US Food and Drug Administration (FDA) released two new guidance documents to help companies comply with the December 20, 2016 final rule establishing postmarketing safety...
MassBio is a non-profit organization that represents and provides support for the life sciences supercluster in Massachusetts. MassBio is committed to growing the industry, adding value to...
Regulatory Sciences
Throughout 2017, the FDA focused its attention on the regulation of generic drug products. In 2015, the Agency issued only two generic-related guidance documents. In 2016, there were seven. In 2017,...
Clinical Research Solutions
Earning FDA approval for your drug program is a journey. A misstep at any point of that journey could jeopardize your chance at getting your drug approved. That’s why it’s so important to have a...
At the beginning of each federal fiscal year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. I find that reviewing these metrics provides a valuable...
Quality & Compliance
Last week, I introduced a two-part series on transformation leadership. We defined transformational leadership, explored the concept, and discussed the benefits of adopting this approach. Well, now...
Selecting the right contract research organization (CRO) is one of the most important decisions you, as a sponsor, must make. That’s because CROs can improve efficiency and increase productivity,...
Quality & Compliance
A couple of years ago, an organization asked me to present to their Leadership Team regarding transformational leadership. They wanted to have a better understanding of what makes an organization...
Quality & Compliance
Here I provide some key summaries and considerations relative to FDA’s draft guidance that was submitted for review and comment in June 2017. If you don’t want to review the entire guidance, here are...
Quality & Compliance
A survey of FDA Form 483 observations issued to the 503B pharmacy industry reveals that outsourcing compounders are struggling to implement and manage compliant and risk-based approaches to aseptic...
Quality & Compliance
You live and operate in a regulated industry. Obviously, it’s crucial that you stay in compliance during your clinical trials. That’s because failure to do so has enormous and expensive consequences....
Quality & Compliance
In 2016, the FDA issued hundreds of 483 observations across the Drug and Device industries for failing to thoroughly review or investigate issues. This topic consistently hits the top five most...
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...