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Generic medicines

FDA aims to speed up approvals of generic drugs

New guidance highlights common deficiencies in generic drug applications to help applicants gain approval more quickly.

Generic medicines ss 18


New guidance published by the FDA highlights common deficiencies in generic drug applications to help applicants gain approval more quickly

The US Food and Drug Administration (FDA) has published guidance aimed at speeding up approvals of generic drugs, helping manufacturers reduce the number of reviews needed to gain approval.

The guidance, ‘Good ANDA [Abbreviated New Drug Application] Submission Practices’, highlights common and recurring deficiencies the FDA says it sees in generic drug applications that often lead to their applications being delayed after undergoing multiple reviews.

It takes on average around four review cycles for an ANDA to reach approval, often because an application is missing necessary information.

The FDA is also publishing companion literature ‘Manual of Policies and Procedures [MAPP] — Good ANDA Assessment Practices’, which formalises the outline of more streamlined ANDA assessment practices for FDA staff.

The review process will now include templates aimed at making the process more efficient and complete.

More support offered

The MAPP sets out that when the FDA has found an ANDA cannot be approved in its current form, application reviewers should provide more detail to the applicants to explain the issues with the applications.

They can also outline details on what information should be provided and give more detail on what additional information a further application would need to support the approval of an application.

In a statement, FDA commissioner Scott Gottlieb said: “There are many times when the FDA must ask applicants for additional information to determine that the requirements for approval have been met, even if an application meets the threshold requirements for filing. These multiple cycles of review are costly and inefficient.”

The moves have been undertaken as part of the FDA’s Drug Competition Action Plan, which in addition to improving the generic review process, aims to reduce gaming by branded companies and resolve scientific and regulatory obstacles that can make it difficult to win approval of generic versions of some drugs.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204193

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