Paper Review Records
All Paper Review Records
5 valid samples · Newest publication first
Review days = acceptance date − received date. PDF, DOI, and publisher-page sources are retained.
Non-approval in the sunlight: FDA’s CRL disclosures, the limits of confidentiality, and lessons from the EMA
AuthorsGabriela Lenarczyk; Timo Minssen; Aaron S Kesselheim
Affiliations1. Center for Advanced Studies in Bioscience Innovation Law, Faculty of Law, University of Copenhagen , 2300 Copenhagen ,; 2. Program on Regulation, Therapeutics & Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School , Boston, MA 02115 ,
Regulating human reproductive and developmental biotechnologies: a UK reference model
AuthorsEmma Cave
Affiliations1. Durham Law School, Palatine Centre, Durham University , Durham DH13LE ,
The biologics manufacturing patent notice challenge: a comparative examination
AuthorsOsmat Azzam Jefferson; Arti Rai
Affiliations1. Senior Research Fellow, Duke Law Center for Innovation Policy, 2024–2025; now at Azzam Research Group; 2. Duke University School of Law , Durham, NC ,
Biobanks as fiduciaries of biosamples and data: a legal and ethical analysis in the light of international standards
AuthorsTatsuaki Tsuruyama; Takuya Hiratsuka
Affiliations1. Department of Drug Discovery Medicine, Graduate School of Medicine, Kyoto University , Shogoin-kawahara-cho 53, Sakyo-ku, Kyoto 606-8507 ,
Neurotechnological cognitive enhancement and human rights: a complex dynamic between empowerment and constraint
AuthorsTimo Istace; Kristof Van Assche
Affiliations1. Faculty of Law, University of Antwerp , Antwerp ,
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