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  • Regulatory NewsRegulatory News

    Should the US government share the Moderna COVID vaccine recipe?

    As much of the developing world struggles to gain access to COVID-19 vaccine doses, some legal experts say the key lies in having the US government share the step-by-step instructions for manufacturing and testing the Moderna mRNA vaccine with other manufacturers.   In a recent Health Affairs blog , Christopher J. Morten, Zain Rizvi, and Ameet Sarpatwari made the case that the US government, through its contract with Moderna, has both access to the details of how the ...
  • Regulatory NewsRegulatory News

    FDA issues draft guidance on electronic 510(k) submissions

    The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance to assist sponsors in using an electronic template for submitting a premarket notification 510(k).   In the draft guidance , FDA said it will accept the electronic Submission Template and Resource (eSTAR) template for applications to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).    The guidance implements section 745(A)(...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA posts guidance on reclassification of certain implantable devices

    Australia’s Therapeutic Goods Administration (TGA) has released guidance to help manufacturers of spinal implants and medical devices that come into direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) to transition to new regulatory requirements.   Currently, TGA treats spinal implants as Class IIb medical devices. Products in direct contact with the heart, CCS or CNS are in Class IIa. In 2019, TGA proposed moving some sp...
  • Regulatory NewsRegulatory News

    Drugs for non-TB pulmonary disease see new FDA guidance

    A new draft guidance from the US Food and Drug Administration (FDA) lays out considerations for sponsors who are developing drugs to treat certain lung infections caused by a mycobacterium related to the organism that causes tuberculosis.   The draft, posted to the FDA website on Tuesday, guides developers of drugs to treat nontuberculous mycobacterial pulmonary disease caused by Mycobacterium avium complex (MAC). It follows an April 2019 public workshop held by FD...
  • Feature ArticlesFeature Articles

    China’s data localization‒centric policies and their impact on human research

    This article reviews Chinese laws governing healthcare data and genomic resources during 1998-2021 and their impact on clinical research in humans by pharmaceutical companies. Companies conducting research in humans must be vigilant about complying with complex legal requirements governing the research and identifying potential risks and mitigation strategies for compliance.   Introduction The analysis includes review of various legal requirements issued by the Peo...
  • ReconRecon

    Recon: Marks takes over CBER's vaccines office; Pfizer submits data on COVID vaccine for children ages 5-11

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A top FDA official moved on Monday to take over the agency’s vaccines office. ( NYTimes ) ( Endpoints ) Pfizer begins study of mRNA flu vaccine ( Reuters ) Pfizer submits data for COVID-19 vaccine use in younger kids ( Reuters ) Merck Nears Deal to Acquire Acceleron Pharma ( NYTimes ) Lilly to cut price of Lispro insulin injection by 40% from Jan. 1 ( Reuters...
  • Regulatory NewsRegulatory News

    ISPE: Global regulators discuss GMP deficiencies, data integrity, real-world evidence

    The COVID-19 public health emergency has prompted regulators to take a different approach to uncovering data integrity violations in virtual inspections compared to onsite inspections, said an official with Australia’s Therapeutic Goods Administration (TGA). The official also provided an update on the status of the EU’s good manufacturing practice (GMP) guide Annex 1, which addresses the manufacture of sterile medicinal products, at a 24 September panel discussion sponsore...
  • Regulatory NewsRegulatory News

    WHO seeks input on medicines to prioritize for BCS-based biowaivers

    The World Health Organization (WHO) is seeking input on the fourth set of medicines to prioritize for biopharmaceutics classification system (BCS)-based biowaivers to ease in vivo study requirements for generic drugs.   The 12 medicines the agency is proposing to prioritize include several cardiovascular and anti-infective medicines, as well as the antidepressant drug amitriptyline.   Since piloting an approach to characterizing the solubility profile of medicine...
  • ReconRecon

    Recon: Pfizer begins Phase 2/3 trial of oral drug for COVID prevention; Biohaven's multiple system atrophy candidate fails in Phase 3

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves add-on drug for ages 10 & up with rare forms of high cholesterol ( FDA ) Biohaven's drug candidate for neurological disorder fails study ( Reuters ) Pfizer begins study of oral drug for prevention of COVID-19 ( Reuters ) Acceleron Is in Advanced Talks for $11 Billion Sale ( Bloomberg ) ( Endpoints ) New ARIA cases dog Biogen's Aduhelm launch in a...
  • 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...