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Animal Testing

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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

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. The draft guidance recommends that no more than 15 questions are included in the briefing package.

Therapies

Therapies FDA Production Disease

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

Specifically, FDA is proposing to classify blood irradiators intended for the prevention of transfusion-associated graft versus host disease into Class II and blood irradiators intended for prevention of metastasis by irradiating intra-operatively salvaged blood of cancer patients undergoing surgery into Class III.

Regulations

Regulations FDA Science Production

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Drug Discovery Digest

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

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Webinars

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