New GDUFA Rules: What Does It Take to Be Successful?

  • April 24, 2019
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GDUFA II was signed into law in 2017 effectively reauthorizing GDUFA I for fiscal years 2018 through 2022.  The continuing goal of the amendment is to facilitate timely access to high-quality, affordable generic drugs. Here are six things that Sponsors should do to significantly increase the chances of getting their ANDA submitted and approved under […] READ MORE...

How to Survive a Multi-Year Consent Decree

  • March 20, 2019
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Operating a business under a Consent Decree is extremely difficult; there is no area of the business that goes unaffected. In addition to fines that could reach $500 million, a three to five-year Consent Decree can result in additional penalties, remediation expenses, lost sales, and diminished stock value. That’s just the financial aspect. A Consent […] READ MORE...

How Working with a Consultant Improves Cost Efficiency, Speed, Completeness of Generic Applications

  • February 13, 2019
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Getting through the process of compiling an ANDA and submitting it for approval is challenging. The application is termed “abbreviated” because applicants are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Still, applicants must scientifically demonstrate that their product performs in the same manner as the innovator […] READ MORE...

Year in Review: Taking a Look at Pharma’s Top News Stories & Events from 2018

  • January 9, 2019
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From FDA’s approval of the first cannabis-based product in the U.S., to the classification of two Apple Watch apps and changes in the Agency’s submission requirements related to Sponsor meetings, it’s safe to say 2018 was a busy year for all of us.  As we look back on all that has happened throughout the year, […] READ MORE...

Outsourcing Functions Doesn’t Mean You’ve Outsourced Compliance Obligations

  • December 4, 2018
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Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic view, successful Sponsors understand the need to leverage the knowledge and resources that external specialist organizations bring to the table. Sponsors of every […] READ MORE...

How GDUFA II Impacts the Timing & Approval Process for Generic Drug Sponsors

  • November 6, 2018
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Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first enacted the Generic Drug User Fee Amendment (GDUFA I) in 2012. After negotiations between the FDA and industry representatives, and with input from public stakeholders, Congress mapped out the concept that generic drug sponsors would pay a user fee […] READ MORE...

Why It’s Always Smarter to Play the Long Game When Planning Your FDA Submission

  • October 24, 2018
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The drug development process is long and expensive. You are doing yourself and your product a huge advantage if you enter and go through the process with a well-researched plan. When planning your FDA submission, you need to “play the long game.” This means that you must have more than just set a goal. It’s […] READ MORE...

Pros and Cons of Working with a CRO

  • October 18, 2018
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Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory Obligations (TORO) brings with it a range of advantages to the Sponsor. However, because the Sponsor is ultimately responsible, they must be aware of the […] READ MORE...

Predicting the Success of a Submission Issue Meeting Following Initial IDE Disapproval

  • October 2, 2018
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Before using a significant risk medical device in a clinical study, sponsors must first obtain FDA approval. Frequently, the request for an investigational device exemption (IDE) is disapproved, and the impact of this disapproval can be significant, as sponsors have invested a great deal of time and resources into development of the device before they […] READ MORE...

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...