ReconRecon
Recon: PhRMA weighs legal options as US pricing reforms move through Congress; Europe to consider dose-sparing to increase monkeypox vaccine
Posted 11 August 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA-led study highlights tradeoffs in drug promotion on social media
Posted 11 August 2022 By Mary Ellen Schneider
Providing both benefit and risk information within character-space-limited (CSL) drug promotions on social media platforms like Twitter improved recognition of risks but made it less likely that consumers would click links for additional...
Regulatory NewsRegulatory News
FDA Official: EU privacy regulations impede BIMO inspections, application reviews
Posted 10 August 2022 By Ferdous Al-Faruque
According to a US Food and Drug Administration (FDA) lawyer, the European Union’s privacy regulations are a headache for researchers and regulators trying to share data. Heather Messick, the former lead policy analyst on the EU’s General...
Regulatory NewsRegulatory News
Study: Accelerated approval pathway working as intended in most cases
Posted 10 August 2022 By Jeff Craven
Over the last several decades, the US Food and Drug Administration’s (FDA) accelerated approval program has largely been working as it was designed to, with about half the products using the pathway being converted to traditional approva...
Regulatory NewsRegulatory News
FDA issues Jynneos EUA to stretch monkeypox vaccine supply
Posted 09 August 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Bavarian Nordics’ monkeypox vaccine Jynneos to be administered to adults intradermally. The move is meant to significantly increase the availabili...
Regulatory NewsRegulatory News
Drugmakers request changes to FDA’s mass balance studies guidance
Posted 09 August 2022 By Joanne S. Eglovitch
The pharmaceutical industry is calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on radiolabeled mass balance studies, suggesting the guidance be revised to require fewer subjects, and mention a male prefe...
Regulatory NewsRegulatory News
Legal Expert: Too early to tell if SCOTUS ruling will chill FDA regulation
Posted 09 August 2022 By Ferdous Al-Faruque
When the majority of the US Supreme Court (SCOTUS) in late June said that an Obama-era Environmental Protection Agency (EPA) policy to curb climate change was a regulatory overreach, legal experts wondered if it would have a chilling eff...
ReconRecon
Recon: Pharma industry laments Senate drug pricing bill; GSK, Mersana sign $1.4B preclinical ADC deal
Posted 09 August 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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