• ReconRecon

    Recon: US signs $3.2B deal for Pfizer-BioNTech vaccines; Novartis said to lean toward spinoff of generics unit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA recommends inclusion of BA.4, BA.5 subvariants in COVID boosters ( Reuters ) As booster season awaits, US re-ups supply of Pfizer Covid-19 vaccine with new $3.2B deal ( Endpoints ) ( Reuters ) ( Fierce ) ( Bloomberg ) Pfizer asks for formal U.S. approval of oral COVID treatment Paxlovid ( Reuters ) Is It Time To Think Beyond mRNA For COVID Vaccines? FDA Ad...
  • Regulatory NewsRegulatory News

    ICMRA explores hybrid inspections, postapproval changes with new pilots

    A global regulatory group is seeking industry participants for two pilot programs exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and for reviewing postapproval changes.   The International Coalition of Medicines Regulatory Authorities (ICMRA) announced the pilots on 24 June. The group said that the pilots were prompted by its July workshop which “highlighted the need for more convergence on CMC [chemistry, manufac...
  • Regulatory NewsRegulatory News

    CAR T cell product development guidance: Comments ask for CMC details

    Both industry and clinicians asked the US Food and Drug Administration (FDA) for clarification related to the evaluation of cellular starting materials in its draft guidance on chimeric antigen receptor (CAR) T cell product development.   The public comments also sought more details on change management and how the guidance applies to other genetically modified products.   The draft guidance , issued on 15 March 2022, provides recommendations on chemistry, manufac...
  • ReconRecon

    Recon: Pfizer, BioNTech to test universal coronavirus vaccine; ARCH raises $3B fund for biotech startups

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA's VRBPAC votes in favor of adapting the Covid-19 vaccine to the latest Omicron variant ( Endpoints ) ( STAT ) ( Reuters ) ( The Pink Sheet ) FDA: Don’t rush a move to change the Covid-19 vaccine composition ( STAT ) BioNTech, Pfizer to start testing universal vaccine for coronaviruses ( Reuters ) US Health Officials Announce New Monkeypox Vaccination Plan ...
  • Regulatory NewsRegulatory News

    Former FDA cybersecurity guru warns of ‘catastrophe’ without dedicated staff

    The former top US Food and Drug Administration (FDA) cybersecurity expert says it’s only a matter of time before disaster strikes in the form of a medical device exploit that could harm patients. To get ahead of the problem, he said the agency needs to hire dedicated cybersecurity staff.   For the past year and a half, Kevin Fu, a cybersecurity professor from the University of Michigan, has been on loan to FDA as the acting director of medical device cybersecurity at t...
  • Regulatory NewsRegulatory News

    VRBPAC recommends addition of Omicron-component to future boosters

    A panel of experts recommended the inclusion of an Omicron component in future COVID-19 vaccine boosters in the United States. Public health officials suspect another surge in COVID-19 cases this fall and are considering boosters with an updated strain composition in hopes that vaccine targeting a more recent strain of the virus will be more effective.   FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 28 June to discuss whether the a...
  • ReconRecon

    Recon: EU approves two Sanofi treatments for rare diseases; Novartis to cut 8,000 staffers as part of global reorganization

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US PDUFA Collections Exceeded Target In FY 2021, While GDUFA Fell Short ( The Pink Sheet ) Four months after CRL due to contaminant worries, Gilead returns to FDA for next-gen HIV drug ( Endpoints ) A decade after its first approval, FDA expands weight loss pill's label for use in adolescents ( Endpoints ) Biden and G7 nations offer funds for vaccine and medical ...
  • Regulatory NewsRegulatory News

    FDA proposes rule broadening nonprescription drug access for consumers

    The US Food and Drug Administration (FDA) has issued a new proposed rule that would allow drug companies to add conditions for consumers to access nonprescription drug products.   A limitation of current nonprescription drug labeling is that it doesn’t always adequately communicate the information consumers need to self-select a product on their own. FDA said the goal of the proposed rule is to increase access to new nonprescription drugs where drug labeling alone is i...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA adds chapters on SaMD, personalized devices to clinical evidence guidelines

    Australia’s Therapeutic Goods Administration (TGA) has updated its clinical evidence guidelines for medical devices, adding new chapters on software as a medical device (SaMD) and personalized medical devices (PMDs), prompted by regulatory frameworks launched in February 2021.   The PMD special topic describes the nature and type of clinical evidence that is needed to show the performance and safety of the devices, which are personalized for individual patients using t...
  • Regulatory NewsRegulatory News

    FDA official: Virtual audits, records requests may be sticking around

    CHICAGO – The US Food and Drug Administration (FDA) plans to use a hybrid inspection model going forward as it eases out of its pandemic response mode, combining a mix of record requests, remote interactive evaluations (RIEs) with onsite inspections if needed, asserted Alonza Cruse, director of FDA’s pharmaceutical quality operations.   Cruse discussed how the agency is transitioning to normal operators at the 22 June Drug Information Association (DIA) annual meeting ...
  • Regulatory NewsRegulatory News

    Oligonucleotides: FDA drafts clinical pharmacology guidance

    The US Food and Drug Administration (FDA) last week issued draft guidance spelling out its expectations for the types of clinical pharmacology assessments that should be conducted during the development of oligonucleotide therapies. The agency notes that several oligonucleotide therapies have been approved for rare diseases in recent years and that such treatments are now in development for common chronic diseases.   While the synthetically modified ribonucleic acid (R...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on food effect studies, issues draft on contamination prevention for non-penicillin beta-lactam drugs

    The US Food and Drug Administration (FDA) recently issued two guidances for industry: a final guidance on how to conduct food effect studies for oral drugs being considered for investigational new drug (IND) and new drug applications (NDAs), and a draft guidance outlining a current good manufacturing practice (CGMP) framework for preventing penicillin from cross contaminating non-penicillin beta-lactam drugs and compounds. Food effect studies   The final guidance on...