(2 of 4) Transitioning from Clinical Research to FDA Review: Clinical Data Application Assembly Team

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Are you planning, or currently in, the process of building your submission clinical data package for a New Drug Application (NDA) or Biologics License Application (BLA)? It can be a complicated process, and in this blog series, we are discussing some of the most important considerations to keep in mind while preparing for FDA submission of clinical data and analytics. Our last post covered the process of preparing the application deliverables to showcase all of the safety and efficacy evidence on your new biologic or pharmaceutical. This time, we are looking specifically at the team members you will need to assemble to ensure the process is smooth and flawless.

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(1 of 4) Transitioning from Clinical Research to FDA Review: Preparing Submission Deliverables

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The process of developing new pharmaceuticals and biologics is long-drawn, pricey, and heavily regulated. After drug discovery and years of pre-clinical and clinical research, a regulatory authority, such as the U.S. Food and Drug Administration (FDA), must review all animal and human data regarding a product’s safety, efficacy, and biological mechanisms. Successfully achieving market approval requires not only a safe and effectual therapy but also accurately presenting all of the evidence to prove it works and is safe for use. In this blog series, we will be reviewing some of the most important components necessary for filing a New Drug Application (NDA) or a Biologics License Application (BLA): the deliverables, the people, the timeline, and the budget. Today, let’s start with the deliverables.

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6 Tips for Communicating with the FDA During Product Development

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If you are reading this, you are likely in the process of developing a new medication or medical device for FDA approval. Maybe your product is nicely progressing through pre-clinical trials and you’re in the process of building your clinical trial protocols. Maybe you’re evaluating the pharmacology and toxicology data, or maybe you’ve already submitted the IND. But have you reached out to your Regulatory Project Manager (RPM) at the FDA yet?

Communicating with the FDA is an important aspect of clinical research and provides the opportunity to assure your research is following all regulatory and safety guidelines. The RPMs are the primary points of contact between you and the FDA and will facilitate the resolution of conflicts or concerns between you and the review team. They can also offer advice throughout the development process on topics ranging from clinical and statistical protocols to safety and product quality. Read more

FDA Modernizes Clinical Trial Designs

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Master Protocol Designs Mean Increased Competition

The FDA has updated and modernized its clinical trial designs. That means a lower cost, more efficient process leading to a more competitive market and lower prices. Not only will this make it easier to bring new treatments to market, it will also increase the amount of similar treatments. That means shorter time frames for companies first to market to have a monopoly over treatments. It also means patients have greater choice within a class of drug. Read more

How Your Partners Might Fail to Properly Understand Regulations

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None of your partners are trying to make your late stage approvals process difficult. But they might be doing it anyway.

It’s not uncommon for the root of a problem to lie not with your organization, but with a partner CRO. Here are some of the most common ways partner organizations can complicate your FDA approvals process: Read more

Contentious FDA Controversies in 2018

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In a sense, FDA regulations are a game of political football. The goal posts are always moving. As new administrations come in, so do new administrators. The current year is no different, with a number of areas shaping up to be contentious points with regard to FDA approvals. Read more

Submissions Are Significantly More Difficult Than Clinical Trials

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Protocol DevelopmentThere’s no two ways about it: Submitting your work is significantly more difficult than earlier stages of clinical trials. That’s because you have to integrate all of your previous analysis into a single, cohesive whole. Those studies might stretch back as far as a decade. What makes the process even more challenging is that these studies must conform with current FDA standards.

You will get some guidance at the end of Phase Two, but that guidance might not be worth much by the time Phase Three comes along. It will have driven your research and analysis throughout Phase Three, but it won’t tell you much about how you should present your data and analysis to the FDA when it comes time for Phase Three approval. Read more

Speed Or Accuracy? You Need Both.

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Speed Or Accuracy? Which Do You Need More?

Of course, this is a false dichotomy. You need both from your biostatistical contract research organization (CRO). Inaccurate research and data analysis isn’t just useless, it’s very costly — to the tune of one million dollars a day. That doesn’t even include the cost to your organization’s reputation or a potential exodus of investment dollars. Read more

Prepare now for adoption of ADaM standard

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What’s on the horizon: mandatory FDA PDUFA V

Per PDUFA V Commitment, FDA shall issue final guidance on the standards and format of electronic submission of drug marketing application by end of 2014. All new original NDA and BLA submissions, supplements and amendments are required to follow the final guidance by end of 2016. All original commercial INDs and amendments are required to follow the guidance.

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