The US Food and Drug Administration (FDA) admonished Japanese pharmaceutical manufacturer Toyoba Co. in a recent warning letter for taking a lax approach to fixing microbiological contamination issues and resolving data integrity problems that included falsification of data.   The firm’s failure to report accurate data “compromised the sterility assurance of drug products released from the facility and may have increased risks to patients,” wrote FDA in the 19 August...

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 ( ...

The US Food and Drug Administration (FDA) announced on Monday that its review of final results from postmarket surveillance of transvaginal mesh devices meant to treat pelvic organ prolapse (POP) found that patients who received mesh repair had increased risk of mesh exposure and tissue erosion compared to patients whose prolapse was repaired with native tissue.   “Therefore, the FDA continues to believe that these devices do not have a favorable benefit-risk profile,”...

In this article, the authors provide an overview of recent US Food and Drug Administration (FDA) interest and activity relating to the materials in implants regulated as medical devices. Since 2019, the increase in public and regulatory scrutiny of medical implants has resulted in an FDA advisory committee meeting, revised corrosion testing guidance, and proposed new labeling disclosures.   Introduction Medical devices offer innovative ways of treating various cond...

The Senate Appropriations committee has completed its markup of the FY2022 budget for the US Food and Drug Administration (FDA), advancing by a 25-5 vote a bill that would hold the agency to a $200 million increase in its budget authority.   The bill exited the Appropriations subcommittee responsible for FDA funding on Monday with no objections to the Senate’s proposed 6% increase for the agency over FY2021 figures. (RELATED: Senate subcommittee advances FY2022 FDA f...

Remote audits conducted by notified bodies have been successful in ensuring that medical device manufacturers are complying with the EU’s Medical Device Regulation and In Vitro Diagnostics Regulation, according to a recently conducted survey  of 46 notified bodies, with remote audits uncovering roughly the same number of deficiencies as onsite audits.   The survey was conducted by the European Association of Medical Device Notified Bodies (TEAM NB), located in Liège...

The regulation of medical devices in the US has grown increasingly complex, with multiple pathways to gain marketplace entry and a shift toward collecting evidence in the postmarket setting.   The findings come from a sweeping study of more than 40 years of medical device regulation by the US Food and Drug Administration (FDA), beginning with the Medical Device Amendments of 1976, which first provided the agency with premarket review authority for devices. The analysis...

In a unanimous vote, the Federal Trade Commission (FTC) has decided to focus law enforcement efforts on repair restrictions that impede or prevent consumers and businesses from repairing products they own.   “While unlawful repair restrictions have generally not been an enforcement priority for the Commission for a number of years, the Commission has determined that it will devote more enforcement resources to combat these practices,” FTC said in a new policy statemen...

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...

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...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US At the FDA’s urging, Pfizer-BioNTech and Moderna are expanding their studies of children 5 to 11 ( NYT ) Bristol Myers withdraws Opdivo in liver cancer as fallout from FDA meeting continues ( Biopharma Dive ) Shelling out $5B+, PerkinElmer pays the big bucks for antibody and reagent player ( Endpoints ) House Democrats expand probe into political interference ...

The US Food and Drug Administration is seeking eight new members for its Patient Engagement Collaborative (PEC), a group charged with gaining meaningful patient input into medical product development and regulatory decision making.   The 16-member panel includes patients, caregivers, and advocates who serve for 2 to 3 years. The panel is a joint effort between FDA and the Clinical Trials Transformation Initiative . Panel members are expected to participate in two to f...