• Regulatory NewsRegulatory News

    Pharmaceutical trading partners lagging in exchanging electronic product information

    Pharmaceutical trading partners are behind the curve in exchanging electronic product information with each other under a mandate established by the Drug Supply Chain Security Act (DSCSA) that requires these exchanges go live by 27 November 2023.   Roughly half of manufacturers and distributors say they are currently exchanging EPICIS Electronic Product Code Information Services (EPICIS) data with each other, while these data are not being exchanged at all between dist...
  • Regulatory NewsRegulatory News

    FDA unveils proposed changes to OTC sunscreen labeling, active ingredients

    The US Food and Drug Administration (FDA) is proposing several changes for over-the-counter (OTC) sunscreen products, from new labeling requirements to substantially reducing the number of active ingredients to be generally recognized as safe and effective (GRASE) for marketing.   The proposed order , which was announced on 24 September 2021 and has a 45-day public comment period, closely follows the agency’s 2019 proposed rule on sunscreens. It also includes change...
  • ReconRecon

    Recon: CDC chief overrules panel on boosters for at risk workers; GE drops $1.45B to buy imaging firm BK medical

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US GE Healthcare drops $1.45B to buy BK Medical, bringing its ultrasound franchise to the OR ( Fierce ) CDC Chief Overrules Agency Panel and Recommends Pfizer-BioNTech Boosters for Workers at Risk ( NYTimes ) ( Reuters ) Biden announces expanded booster rollout amid confusion over eligibility ( Politico ) ( STAT ) Boosters for Moderna and Johnson & Johnson vaccin...
  • Regulatory NewsRegulatory News

    Review highlights lack of consistency in FDA’s ‘close call’ approvals

    The process used by the US Food and Drug Administration to vet new drugs and biologics is inconsistent in borderline cases and fails to rely on evidence standards used in previous decisions, according to findings from a case series that examined the process across 22 "close call" applications in recent years.   The findings, published as a case series in the Annals of Internal Medicine , show that in some cases the agency revised an initial denial based on a reinter...
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    Three foreign OTC firms slapped with warning letters for GMP testing violations

    Slipshod testing of two over-the-counter (OTC) analgesics along with improper marketing of one led the US Food and Drug Administration (FDA) to issue three warning letters to manufacturers located outside the US. Additionally, the agency continued its crackdown on imported hand sanitizers.   The recipients of the warning letters, which were all issued in mid-September, include Laboratorio Pharma International in Tegucigalpa, Honduras, a manufacturer of antibiotics and ...
  • RoundupsRoundups

    Euro Roundup: CHMP recommends drugs from Biogen and Roche, knocks back Pfizer filing

    The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended nine medicines including Biogen’s Vumerity (diroximel fumarate) and Roche’s Gavreto (pralsetinib) for approval.   CHMP voiced support for the approval of RET receptor tyrosine kinase inhibitor Gavreto in non-small cell lung cancer on the strength of data from a Phase I/II clinical trial. Biogen received the backing of the committee for its multiple sclerosis drug...
  • ReconRecon

    Recon: FDA authorizes boosters for at-risk and older Americans; Novavax applies for WHO emergency listing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Authorizes Pfizer Booster Shots for Older and At-Risk Americans ( NYTimes ) ( Reuters ) ( STAT ) ( FDA ) Pfizer CEO rallies staff to fight Democrats’ drug price negotiation ( Politico ) Moderna chief executive sees pandemic over in a year ( Reuters ) Novavax applies to WHO for emergency listing of COVID-19 vaccine ( Reuters ) Biosimilar Drugs Are Cheaper ...
  • Regulatory NewsRegulatory News

    FDA publishes first batch of device material safety reports in ECRI partnership

    The US Food and Drug Administration (FDA) on Wednesday published the first four reports on the safety and performance of materials commonly used in implantable medical devices.   FDA commissioned ECRI, a nonprofit organization initially founded as the Emergency Care Research Institute that focuses on safety, quality and cost-effectiveness in health care settings, to compile the reports. Each report is based on a "comprehensive literature search and systematic review to...
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    FDA OKs new pathology AI software, launches AI-enabled device database

    The US Food and Drug Administration (FDA) has authorized software designed to help pathologists detect prostate cancer in digitally scanned slides from prostate biopsies. Separately, the agency announced Wednesday that it has made available a list of devices that use artificial intelligence and machine learning.   The newly authorized software, called Paige Prostate, is the first artificial intelligence (AI) tool okayed by FDA for in vitro diagnostic use for prostate...
  • RoundupsRoundups

    FDA Approvals Roundup: Exkivity, Tivdak, Opzelura

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Exkivity okayed as oral therapy for advanced NSCLC with certain mutations Takeda’s Exkivity (mobocertinib capsules) has been granted accelerated approval as an oral treatment for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as d...
  • ReconRecon

    Recon: FDA approves Incyte's eczema cream with boxed warnings; Biden pledges 500M doses of Pfizer vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden pledges 500 mln more COVID-19 vaccine doses as U.S. pressured to do more ( Reuters ) A CDC panel is meeting to decide who should get Pfizer boosters. ( NYTimes ) ( Reuters ) FDA approves Seagen/Genmab’s antibody-drug conjugate Tivdak for women with advanced cervical cancer ( PMLive ) FDA approves Incyte's eczema cream with boxed warnings ( Reuters ) ( En...
  • Regulatory NewsRegulatory News

    Vaccines Europe makes the case for vaccine-specific HTA

    A new position paper from Vaccines Europe calls for an EU-wide committee and effort to implement clinical health technology assessment (HTA) methodologies that are specific to vaccines.   The vaccine-specific initiative would be part of a broader effort by the European Commission (EC) to institute common HTA methodologies and tools throughout the EU. Vaccines Europe, together with the European Federation of Pharmaceutical Industries and Associations’ (EFPIA), is seekin...