• Regulatory NewsRegulatory News

    Review: FDA device approval pathways more complex than ever

    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...
  • Regulatory NewsRegulatory News

    Another drug firm faces potential fines for research non-reporting

    A small Georgia pharmaceutical company has received a notice of noncompliance from the US Food and Drug Administration (FDA) for not registering clinical trial results in a central government registry, as required by federal law.   The 26 July letter is the second issued by FDA for noncompliance with federal research reporting requirements outlined in Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). If results are not reported within on...
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    FTC to focus enforcement action on illegal repair restrictions

    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...
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    FDA approves Semglee as first biosimilar interchangeable insulin

    The US Food and Drug Administration (FDA) has approved the first interchangeable biosimilar product, giving the designation to a once-daily insulin product to treat diabetes.   FDA’s designation of Semglee (insulin glargine-yfgn, Mylan) as interchangeable with Lantus (insulin glargine, Sanofi) means that Semglee may now be substituted for the reference product at the pharmacy “without the intervention of the prescriber,” noted FDA in a Wednesday evening press release ...
  • RoundupsRoundups

    FDA Approvals Roundup: Bydureon, Dalvance, Shingrix

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New indications Bydureon use extended for type 2 diabetes in adolescents AstraZeneca’s Bydureon and Bydureon BCise (exenatide extended-release injection) have received expanded indications for improving glycemic control in children aged 10 years or older with type 2 diabetes.   The approval was based on effectiveness and safety findings from a 24-week, d...
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    Digital health collaborative aims to build in equity and inclusion

    A newly minted collaborative of industry, government, and patient groups is seeking to develop a set of best practices that will help make digital health measurement technologies work for all users, regardless of gender, race, ethnicity, and other factors.   The Digital Health Measurement Collaborative Community ( DATAcc ), launched in May 2021, is hosted by the nonprofit Digital Medicine Society (DiMe) and brings together more than 30 organizations, including the US F...
  • ReconRecon

    RECON: FDA halts Pepaxto trials; Pfizer nears $8B in vax sales for Q2

    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...
  • ReconRecon

    Recon: Abbvie and Calico craft $1B deal; Purdue creditors sign deal to shield Sacklers

    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...
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    FDA seeks comments on regulation of kratom, 6 other drugs

    Kratom, a popular but unregulated psychotropic herbal extract, is one of seven currently unscheduled psychotropic drugs that will be reviewed by the World Health Organization (WHO) under the provisions of the international psychotropic convention to which the US is a party.   WHO notified the US and other international parties to the 1971 convention that the seven new psychotropic drugs may be added to its list of scheduled drugs. By law, that notification triggers a r...
  • ReconRecon

    Recon: Shape Therapeutics' $112M gene therapy play; Incyte's cancer drug flops at FDA

    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 ...
  • Regulatory NewsRegulatory News

    FDA seeks new members for Patient Engagement Collaborative

    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...
  • Regulatory NewsRegulatory News

    FDA seeks global shift to include pregnant women in medical research

    The COVID-19 pandemic has put a spotlight on the paradox surrounding the inclusion of pregnant and breastfeeding women in medical research. Even when these women are at higher risk for severe illness and hospitalization, they are unlikely to be included in clinical trials for medical products and vaccines. In a recent article, officials at the US Food and Drug Administration (FDA) signaled their commitment to work with industry and other regulators to support the inclus...