Remove Animal Testing Remove Clinical Development Remove Packaging
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FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

FDA Law Blog: Drug Discovery

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

FDA 64
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Rapid delivery of toxicological material

Drug Target Review

However, developing an accelerated IND application requires that good laboratory practice (GLP) toxicological data must be generated, collected, interpreted and integrated in the IND-enabling data package. FDA no longer has to require animal testing for new drugs. References: 1 Wadman M.

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages. All the while, this efficiency in clinical development requires accelerating CMC by having early-stage studies serve as large stage studies.