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BIO warns members to increase gender diversity; FDA revises guidance to citizen petitions to block abusing the system; FDA finalizes guidance on timing of pediatric studies for atopic dermatitis; FDA finalizes guidance on package type terms and discard statements for injectables; FDA approves first antibiotic under accelerated approval pathway…
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FDA issues draft guidance on monetary penalties for failing to report clinical trials; FDA finalizes guidances on Drug Supply Chain and Security Act; FDA recommends new KASA platform to improve review of applications; EMA publishes concept paper on clinical trials in neonates; Australia unveils strategy for engaging with foreign regulators…
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Infamous blood-testing company Theranos to dissolve; Otsuka's dose-tracking digital pill to be distributed by Magellan Health; FDA finalizes guidances on nonallergic and allergic rhinitis; FDA releases MAPP on how manufacturing facilities are prioritized for inspections; ICH biopharmaceutics classification system-based biowaivers guideline…
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FDA issues draft guidance on use of placebo in only certain oncology trials; FDA drafts guidance on developing products for osteoarthritis; FDA finalizes guidance on microdose radiopharmaceutical diagnostic drugs; FDA finalizes guidance on quality attributes of chewables; Health Canada introduces transparency proposals for pharmaceuticals…
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FDA releases new draft guidances on gene therapy; FDA updates guidance on development of smallpox antivirals; FDA issues draft guidance on hypertension drug development; EMA releases concept paper on drugs to prevent and treat acute kidney injury; Health Canada issues guidance on compliance with notifications of foreign regulatory actions…
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FDA withdraws guidance document on analytical studies for biosimilars; CBER launches new program for early meetings with developers of biologics; FDA updates guidance on major depressive disorder; FDA updates guidance on user fee waivers, reductions, and refunds for drugs and biologics; EMA updates guidances for industry on Brexit…
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FDA issues new guidance on antibiotics for limited patient populations; FDA issues guidance on gathering patient input during drug development; FDA updates inter-center consult request manual for combination products; FDA proposes alternative mechanisms to comply with GMP for combination products; EMA to launch online portal for orphan drug designa…
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