Responding to a 483: 15 Days to Panic or Plan for Success

  • September 18, 2018
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Remember the last time you were pulled over by the police? Maybe you had a tail light out. Perhaps you were speeding. You may have believed that you had done nothing wrong. Regardless of the specific situation, you probably panicked a little. It’s human nature to panic when the government tells you that you’ve done […] READ MORE...

FDA Releases Draft Guidance on Nonprescription Drugs

  • September 17, 2018
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On Tuesday, July 17th, FDA released a new draft guidance entitled “Innovative Approaches for Nonprescription Drug Products.” The guidance discusses two different approaches for making nonprescription drugs more accessible to consumers. Regulatory Pathways for Nonprescription Drugs There are currently two different pathways for nonprescription drugs: Over-the-Counter Drug Review (OTC Monograph Process) New Drug Application (NDA) […] READ MORE...

Generic Failure: Why 90% of ANDAs are Rejected on the 1st Pass

  • August 21, 2018
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Generic drugs are immensely important to the U.S. healthcare system. These drugs account for 89% of the prescriptions dispensed in the United States. And, over the last decade, generic drugs have saved consumers more than $1.67 trillion. In 2017, the FDA’s Office of Generic Drugs approved or tentatively approved 1,027 abbreviated new drug applications (ANDAs), […] READ MORE...

Understanding and Avoiding Common Phase 3 Failure Points

  • July 25, 2018
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By the time the drug development process gets to Phase 3, it seems reasonable to assume that the chance of failure is relatively low. After all, the entire early-development process is at least partially designed to reduce the risk of failure of the longer and more expensive clinical trials. The knowledge gained from the data […] READ MORE...

It’s the FDA Not the NBA: Why Drug Approvals Are Never Slam Dunks

  • June 14, 2018
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Aside from being a spectacular thing to watch, the slam dunk is the highest percentage shot a basketball player can take. The likelihood of getting the ball in the basket is so high that the shot is almost a sure thing. In the world of the FDA, sure things don’t exist.   Approvals are never assured; […] READ MORE...

505(b)(1) vs. 505(b)(2): Choosing the Appropriate Regulatory Pathway

  • April 26, 2018
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Because the FDA is an agency established by a federal law, there are clearly defined pathways along which a drug can be approved. Deciding on the appropriate regulatory pathway for your drug development program is a process that requires an understanding of the content and purposes of sections 505(b)(1) and 505(b)(2) of the Federal Food, […] READ MORE...

FDA Steps up its Game on Generic Drugs: The Story Behind the Recent Focus on Generic Products

  • February 15, 2018
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By Kristen BoothThroughout 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, there were 15 guidance documents (including final, draft, and revised guidance documents) issued regarding ANDAs and/or generic drug products.  Even more noteworthy […] READ MORE...

Finding a Roadmap to Approval – Hint: You Can’t Pick One Up at the FDA

  • January 31, 2018
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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 dependable roadmap that will get you where you want to go. A misconception many sponsors have is that the FDA […] READ MORE...

The Truth Can Hurt – But Hearing It at the Right Time Can Save Time and Money

  • January 24, 2018
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No one has an ugly baby. At least, no one thinks their baby is ugly. Every new parent thinks their baby is the most beautiful baby of all time. The unfortunate fact is that there are ugly babies. We’ve all been in the position of looking at someone’s baby and biting our tongue because we […] READ MORE...

How Independent Audits Help Ensure Compliance and Protect the Drug Development Program

  • November 1, 2017
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You live and operate in a regulated industry. Accordingly, your entire drug development program is overseen and reviewed by the FDA, and the success of your program depends upon compliance with the Agency’s regulations. A successful outcome is determined by whether you have followed the plans detailed in your regulatory strategy, as well as the […] READ MORE...