Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Six U.S. states do not join $26B opioid settlements with distributors, J&J ( Reuters ) ‘We Sent a Terrible Message’: Scientists Say Biden Jumped the Gun With Vaccine Booster Plan ( KHN ) Fauci says he hopes U.S. will have ‘some good control’ over Covid by spring 2022 ( CNBC ) American Medical Association calls for public, private sectors to mandate vaccines ( ...

  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer's COVID Vaccine Gets Full Approval From The FDA ( NPR ) ( NYT ) ( NBC ) Biden calls on companies to mandate vaccines following FDA full approval ( The Hill ) Pentagon set to make Pfizer vaccine mandatory after FDA approval ( Reuters ) New York City, The Country's Largest School System, Mandates Teacher Vaccinations ( NPR ) The U.S. Is Getting a Cra...

  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Maker of Popular Covid Test Told Factory to Destroy Inventory ( NYT ) Acting FDA Chief Janet Woodcock Ruled Out as Biden Nominee ( Bloomberg ) Child Covid-19 hospitalizations soar, filling pediatric wings, data show ( NBC ) White House: More than one million vaccine doses administered in past 24 hours ( The Hill ) Three senators announce positive COVID-19...

MHRA seeks feedback on making personalized medicines at the point of care   The UK Medicines and Healthcare products Regulatory Agency (MHRA) seeking input on whether the production of personalized medicines at the point of care (POC) is sufficiently different from standard manufacturing to require the creation of a new framework.   In contrast to traditional medicine manufacturing, where fewer facilities, working at scale, manufacture products for global distrib...

The rapid expansion and evolution of artificial intelligence (AI) will challenge the current regulatory pharmaceutical and device, according to a new horizon-scanning report from an international consortium of regulators. The ad hoc group recommends a permanent working group to stay abreast of the regulation of AI in the development and assessment of medicinal products.   A 6 August report from the International Coalition of Medicines Regulatory Authorities (ICMRA) d...

An initiative by the European Commission (EC) to boost the development of pediatric drugs and medicines for people with rare diseases has received stakeholder feedback that in many cases expresses concern with the proposed upending of the status quo.   A 60-day period of public consultation for the initiative’s roadmap closed at the end of July; in all, 112 comments were received from individuals, non-governmental organizations (NGOs), public authorities, medical socie...

The European Commission (EC) has affirmed that it plans to launch the Clinical Trials Information System by the end of January 2022, as part of its broader efforts to modernize and streamline the conduct and oversight of clinical trials in the EU.   “The pandemic has clearly shown the importance of efficient clinical trials that do not compromise on rigorous safety and efficacy standards,” said Stella Kyriakides, EC commissioner for health and food safety, speaking o...

The European Medicines Agency (EMA) on Thursday issued an updated reflection paper specifying the good manufacturing practice (GMP) responsibilities of marketing authorization holders under the European Commission (EC) GMP guidelines and other EU legislation.   The paper replaces a draft version issued in January 2020 with only some minor revisions. (RELATED: EMA Consults on GMP Reflection Paper , Regulatory Focus, 22 January 2020).   The paper covers the re...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer sells $7.8 billion in Covid shots in the second quarter, raises 2021 guidance on vaccine sales ( CNBC ) AstraZeneca castoff draws $123M wager on CXCR2 antagonist as Arena lines up a buyout option ( Endpoints ) Opinion: US FDA Should Take Its Time With COVID Vaccine BLAs ( Pink Sheet ) Biden Is Considering A Vaccine Or Testing Mandate For Federal Workers...

An updated reflection paper from the European Medicines Agency (EMA) tackles how statistics should be used in drug development when a comparative assessment of quality attributes needs to be made.   The paper touches on issues that arise both in the development of small molecules and in work being done in the area of biosimilars, where tricky manufacturing challenges and mutable organic molecules make defining the concept of “similarity” a challenge.   EMA’s human ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How Biogen found a believer: At the FDA, a hard-nosed regulator was won over on controversial Alzheimer’s drug ( STAT ) AbbVie hits go on $1B re-upped Calico deal as the Google life science spin-out continues I-O, neuro push ( Fierce ) Biden wants to bolster the pharma supply chain. A major generic plant closing may make that harder ( STAT ) CDC to reverse ind...

The European Medicines Agency (EMA) has adopted a guideline on the quality information that manufacturers of combination products should submit in marketing authorization applications (MAA).   It also incorporates the recent revision of the EU’s Medical Devices Regulations (MDR) in requiring makers of these products to obtain the results of conformity testing of the device part from a notified body. The MDR regulation went into effect in May 2021. (RELATED: EMA Kicks...