FDA Warning Letters: Alerting Signs are Always There

Keep an eye for the warning signs in your internal procedures and processes to reduce the risk of being caught by the FDA.
Oops! I got the FDA warning letter. Now what should I do?  How should I respond to prevent further enforcement actions by the Agency?  And all the other barrage of questions scares you. Look at it differently.  How do you foresee that a warning letter is coming? What are the signs that can help you anticipate a letter from the Agency? If you can do that, then hopefully, you can take steps to avoid one and resolve it before FDA knocks your door.

Warning Letter Trends

In the recent past the FDA has made an effort to speed up the warning letter program. This means that they will no longer build an airtight legal case before issuing the letter. Multiple warning letters are also no longer being issued. In some cases, the FDA has shown that it will not even issue a formal letter before shutting down a facility, recalling products or revoking licenses.
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FDA Enforcement Trends: What to Expect in the Next Three to Five Years

For those who follow FDA enforcement trends, 2015 has been a complicated year. On the one hand, the Amarin decision has challenged FDA’s historical regulation of medical product promotion, and the agency has adopted some flexibility regarding the development of mobile medical applications and laboratory developed tests (LDTs). On the other, the Department of Justice recently announced its renewed focus on assessing executive culpability for corporate violations, and a federal judge just handed down a substantial jail sentence for an FDA-related crime. In our view, this dichotomy is now more the rule than exception, and we expect FDA to continue its practice of enforcing the law energetically against certain actors while it simultaneously develops increasingly balanced positions on discrete health policy issues. We expect the next three to five years to be very active from an enforcement perspective and anticipate upward trends in the number of GMP regulatory enforcement actions, qui tams, track-and-trace violations, executives named as defendants, and oversight of post-market safety signals and related reporting issues (AERs and MDRs).
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FDA Expedited Access Pathway – Smoothing the Route to Market for Innovative Medical Devices

In April of 2015 the Food and Drug Administration (FDA) issued a final guidance document describing the Agency’s newest program for innovative therapies. The document, Guidance for Industry and Food and Drug Administration Staff: Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions (“EAP Guidance”) describes a program intended to expedite the development, assessment and FDA review of innovative medical devices intended to treat life threatening or debilitating diseases.
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