• Regulatory NewsRegulatory News

    FDA tells Dutch API producer to clean up its equipment act

    A Dutch producer of active pharmaceutical ingredients (APIs) was put on notice to adopt more robust equipment cleaning practices and use better safeguards to prevent cross-contamination in a warning letter from the US Food and Drug Administration (FDA) dated 14 June. FDA found the presence of “visible powder residue” on non-dedicated equipment.   The warning letter pertained to Fagron Group B.V.’s manufacturing site in Saint Paul, MN. The company is headquartered in ...
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    COVID-19 therapeutics tracker

    A handful of therapeutics have been approved specifically to treat COVID-19, reduce its severity, or prevent it entirely.   As of July 2022, those treatments include dexamethasone, Avigan (favilavir), Veklury (remdesivir) alone and in combination with Olumiant (baricitinib), Lagevrio (molnupiravir), Xevudy (sotrovimab), Regkirona (regdanvimab), Ronapreve (casirivimab and imdevimab), amubarvimab and romlusevimab (formerly BRII-196 and BRII-198), Actemra/RoActemra (tocil...
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    Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition

    Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of Fundamentals of Medical Device Regulations provides a current view of regulations governing medical devices and IVD and addresses the impact of the application of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) as well as other important changes to...
  • Feature ArticlesFeature Articles

    An update of China’s food safety regulatory framework

    This article reviews the changes in China's national food safety control system and update on national food safety standard system and describes the country's unique regulations and requirements for the regulatory control of infant formula, health foods (functional foods), and food for special medical purposes (FSMP). Keywords – infant formula; food for special medical purposes; food regulatory control; food safety; food standards   Introduction Since the m...
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    FDA calls for inclusion of Omicron BA.4/5 in future boosters

    Heeding the advice of its expert advisory committee, the US Food and Drug Administration (FDA) on Thursday recommended the inclusion of an Omicron BA.4/5 spike protein component in modified COVID-19 vaccine boosters for the upcoming fall and winter seasons.   The recommendation follows a 19-2 vote in favor of adding an Omicron-specific component to future boosters by FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) earlier this week. (RELATED:...
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    PFDD: Draft guidance seeks to demystify clinical outcomes assessments

    The US Food and Drug Administration (FDA) this week issued a sweeping draft guidance intended to help stakeholders incorporate patient experience data through the use of meaningful clinical outcome assessments (COAs). On 29 June, the FDA published a draft guidance titled, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments . It’s the third in a series of four guidances the agency is developing to further ...
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    FDA approval lowers, but doesn’t eliminate disparities in immunotherapy use

    Racial, ethnic and sociodemographic disparities that are present in clinical trials and compassionate use agreements for cancer immunotherapy during the pre-approval period are reduced, but not eliminated after the US Food and Drug Administration (FDA) approves these cancer treatments, according to recent research published in JAMA Network Open .   “The time frame leading up to FDA approval is an important period in which to observe disparities,” Theresa Ermer, MD, of...
  • RoundupsRoundups

    Euro Roundup: MHRA plans wave of medtech regulation after consultation shows support for reform

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to introduce a wave of regulations to reclassify medical devices, strengthen postmarket surveillance and otherwise revise its approach to medtech after seeing support for reform in the 891 responses to its 2021 consultation.   MHRA proposed a slate of medtech reforms considering the Cumberlege Review and the opportunity presented by Brexit. The proposals were intended to improve patient safe...
  • 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...
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    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...
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    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 ...