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

  • November 6, 2018
  • |

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
  • |

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
  • |

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
  • |

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
  • |

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FDA Releases Draft Guidance on Nonprescription Drugs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
  • |

On Tuesday, July 17th, FDA released a new draft guidance entitled “Innovative Approaches for Nonprescription Drug Products.”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
  • |

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
  • |

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
  • |

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
  • |

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...