Regulatory NewsRegulatory News
Health policy experts call for stronger accelerated approval reforms
Posted 06 July 2022 By Mary Ellen Schneider
The US Congress should take concerns raised by the Food and Drug Administration (FDA) seriously and give the agency more authority around accelerated approvals, including the power to expedite the withdrawal of drugs from the market, acc...
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Recon: FDA grants priority review for Biogen-Eisai’s Alzheimer’s drug; Senate Democrats advance drug-price deal
Posted 06 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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Recon: FDA reconvenes adcomm meeting for Amylyx’s Pharma’s ALS treatment; AstraZeneca growing lymphoma pipeline with $1.3B TeneoTwo acquisition
Posted 05 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
This Week at FDAThis Week at FDA
This Week at FDA: User fee timeline, bivalent boosters, and more
Posted 01 July 2022 By Michael Mezher
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest news out of FDA this week was the ag...
Regulatory NewsRegulatory News
FDA calls for inclusion of Omicron BA.4/5 in future boosters
Posted 30 June 2022 By Michael Mezher
Heeding the advice of its expert advisory committee, the US Food and Drug Administration (FDA) on Thursday recommended the inclusion of an Omicron BA.4/5 spike protein component in modified COVID-19 vaccine boosters for the upcoming fall...
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Recon: US signs $3.2B deal for Pfizer-BioNTech vaccines; Novartis said to lean toward spinoff of generics unit
Posted 30 June 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
CAR T cell product development guidance: Comments ask for CMC details
Posted 29 June 2022 By Mary Ellen Schneider
Both industry and clinicians asked the US Food and Drug Administration (FDA) for clarification related to the evaluation of cellular starting materials in its draft guidance on chimeric antigen receptor (CAR) T cell product development.
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Recon: Pfizer, BioNTech to test universal coronavirus vaccine; ARCH raises $3B fund for biotech startups
Posted 29 June 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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China Drug Regulatory Update
Tuesday, 16 August 2022 (11:00 - 12:30PM) 1.0 RAC Credits Member: $150 | NonMember: $175
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Tackling the CMC Challenges for Cell and Gene Therapy Product Development
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Key opinion leaders from academia, industry, and a regulatory agency will discuss these strategies in addressing CGT manufacturing challenges to bring transformative medicines to patients.
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The COVID-19 Impact: How will Regulatory Emerge from the Pandemic?
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Learn how regulatory teams are adapting to this global health crisis and what effects it will have in the short and long term.
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Sponsored Webcast: eCTD Submission Challenges (On-Demand)
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Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.
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Complete WHO Guidance Documentation Bundle
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A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
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Regulatory Policy & Intelligence: Understanding When, Why, and How to Invest in Growing These Capabilities
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Promotion of FDA-Regulated Medical Products
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Orphan Drug Development for Rare Diseases covers every aspect of orphan drug development. Topics include incentives, benefits, patient engagement, designation, marketing authorization, and market access.
     
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