Remove Animal Testing Remove Marketing Remove Packaging
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Levers for Biological Progress

Codon

Though my focus in this essay is narrow — I don’t discuss bottlenecks in clinical trials, human disease, or animal testing — I hope others will take on these challenges in similar essays. This essay focuses on how we might do both, specifically for the cell. Subscribe to Asimov Press.

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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The draft guidance states that only one 90-minute pre-BLA meeting will typically be granted for a specific product or indication planned for an original marketing application. The draft guidance recommends that no more than 15 questions are included in the briefing package.

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Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. This also has clear potential to reduce animal testing, another key commitment made by the Commission.

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Article FDA Thank You FDA proposes first update to orthopedic device coating guidance since 1990s

Agency IQ

FDA proposes first update to orthopedic device coating guidance since 1990s The FDA’s Center for Devices and Radiological Health (CDRH) has issued a new draft guidance specifically laying out the types of information it would want to see in pre-market submission for orthopedic devices with specific coating types.

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Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

Agency IQ

The PPPR framework governs the authorization, sale, and use of PPPs, establishing a pre-market approval process for active substances – the pesticide components which control pests, weeds, and plant diseases – and for synergists and safeners before they can be allowed for use in PPPs.

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Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Sections 5 – 9 are labeled as Part A and cover clinical evaluation considerations.

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Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition

Agency IQ

Hojsik, a member of EP’s Renew Europe group, highlighted the revision of the regulation on the classification, labeling and packaging of chemicals (CLP) and its inclusion of new hazard classes as an important achievement over the past five years.