POL regulation of drugs and vaccines

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33008462 2020. Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study.
32092455 2020. New regulatory strategies to manage medicines shortages in Europe.
32282038 2020. The VACCINES Act, Deciphering Vaccine Hesitancy in the Time of COVID19.
32406905 2020. Navigating regulatory statutes during the Coronavirus Disease 2019.
32509289 2020. The case for compulsory licensing during COVID-19.
32556334 2020. Regulating drugs, medical devices, and diagnostic tests in the European Union: early lessons from the COVID-19 pandemic?
32577858 2020. Pricing vaccines and drugs in Europe: worth differentiating?
32617864 2020. Short and long term impacts of COVID-19 on the pharmaceutical sector.
32646713 2020. Why we should all be more careful in drawing conclusions about how COVID-19 is changing drug markets.
32651020 2020. COVID-19: Regulatory Landscape of Medicinal and Medical Device Products for Human Use.
32653276 2020. The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines.
32654910 ?. Shortage of sedatives and neuromuscular blockers during COVID-19 pandemic: The result of an overstocking procedure in French hospitals?
32716030 2020. National drug shortages worsen during COVID-19 crisis: Proposal for a comprehensive model to monitor and address critical drug shortages.
32716795 2020. Compassionate Release as a "Right" in the Age of COVID-19.
32733682 2020. 'Influence of conflicts of interest on public positions in the COVID-19 era, the case of Gilead Sciences' by Roussel and Raoult (2020).
32758342 2020. Were it business opportunities or hidden risks: Observations on clinical trials and marketing authorizations of Gilead Science's remdesivir in China.
32763102 2020. Medication shortages during the COVID-19 pandemic: Saving more than COVID lives.
32766736 2020. Unwavering Regulatory Safeguards for COVID-19 Vaccines.
32773895 2020. Accelerating regulation in response to COVID-19.
32815510 2020. How Do We Combat Bogus Medicines in the Age of the COVID-19 Pandemic?
32826103 2020. So much at stake: Ethical tradeoffs in accelerating SARSCoV-2 vaccine development.
32870235 2020. Emergency Use Authorizations During the COVID-19 Pandemic: Lessons From Hydroxychloroquine for Vaccine Authorization and Approval.
32908261 2020. How the FDA should protect its integrity from politics.
32908674 2020. Regulatory flexibility for COVID-19 research.
32913283 2020. The global response to the COVID-19 pandemic: how have immunology societies contributed?
32918053 2020. China's coronavirus vaccine shows military's growing role in medical research.
32931162 2020. Up Is Down - Pharmaceutical Industry Caution vs. Federal Acceleration of Covid-19 Vaccine Approval.
32935085 2020. Don't shortchange public trust in science.
32937059 2020. Audio Interview: Operation Warp Speed and Covid-19 Therapeutics.
32943078 2020. Coordinating the research response to COVID-19: Mali's approach.
32958465 2020. Bringing drug production home: how the US is rebuilding the drug supply chain after covid-19.
33009760 2020. Compassionate Drug Use - Time Arising for a New Law in Bulgaria in the Era of COVID-19.
33021187 2020. ELSI Implications of Prioritizing Biological Therapies in Times of COVID-19.
32916069 2020. The American College of Surgeons Response to the COVID-19 Pandemic (Part III): Leadership in a Time of Crisis.
32916074 2020. The American College of Surgeons Response to the COVID-19 Pandemic (Part II) : Advocacy and Public Policy.
32916067 2020. The American College of Surgeons Response to the COVID-19 Pandemic (Part I): Cancer Care, COVID-19 Registry, Surgeon Wellness.
32822866 2020. Advancing COVID-19 vaccines - avoiding different regulatory standards for different vaccines and need for open and transparent data sharing.
32700678 2020. Keep Politics out of Funding Decisions for Medical Research and Public Health.
32843731 2020. Confusion over Europe's data-protection law is stalling scientific progress.
33033702 2020. Medical affairs post-COVID 19: Are we ready to take the baton?
33033703 2020. Pharmacovigilance and assessment of drug safety reports during COVID 19.

33082093 2020. Temporary derogation from European environmental legislation for clinical trials of genetically modified organisms for coronavirus disease 2019.

33132411 2020. Strategic Patenting by Pharmaceutical Companies - Should Competition Law Intervene?
33136427 2020. Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research.
33170810 2020. Emergency seed funding for COVID-19 research: lessons from Johns Hopkins University.
33173230 2020. Impact of COVID-19 on pharmaceutical external innovation sourcing.
33192028 2020. Business-as-Usual will not Deliver the COVID-19 Vaccines We Need.
33196036 2020. How can we evaluate the potential of innovative vaccine products and technologies in resource constrained settings? A total systems effectiveness (TSE) approach to decision-making.
33199075 2020. The role of manufacturers in the implementation of global traceability standards in the supply chain to combat vaccine counterfeiting and enhance safety monitoring.
33201590 2020. Dose Selection in a Pandemic: A Framework Informed by the FDA Animal Rule.
33211534 2020. Consideration Of Value-Based Pricing For Treatments And Vaccines Is Important, Even In The COVID-19 Pandemic.
33213730 2020. Regulation of Cardiovascular Therapies During the COVID-19 Public Health Emergency.

33211535 2020. An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19.

33219926 2020. How to Investigate a Serious Adverse Event Reported During a Clinical Trial for a COVID-19 Vaccine.
33237474 2020. New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19 : In Responding to a Global Health Crisis, Industry is Discovering New, Efficient Ways of Meeting Objectives.
33253920 2020. Expanded Access Programs, compassionate drug Use, and Emergency Use Authorizations during the COVID-19 pandemic.
33262564 2020. ICER's second update to pricing models of remdesivir for COVID-19.
33290568 2020. Vaccine Development: From Laboratory to Policy.
33292374 2020. FDA efficiency for approval process of COVID-19 therapeutics.
C7239779 ?. Compassionate drug use: an imperative challenge for Bulgarian health system during COVID-19.
C7279762 2020. Monitoring investments in coronavirus research and development.
C7286811 ?. Sticky Policies Dysfunctional Systems: Path Dependency and the Problems of Government Funding for Science in the United States.
C7347757 2020. Policy options discussed for pricing novel COVID-19 vaccines/treatment.
C7347759 2020. ICER update to pricing models of remdesivir for COVID-19.
C7692409 2020. EMA s safety monitoring plan for COVID-19 vaccines.
C7661824 2020. EMA guidance on risk management plans for COVID-19 vaccines reviewed.
C7703519 ?. Regulatory agilities in the time of COVID-19: Overview Trends and Opportunities.
C7271643 ?. Assessing resilience of healthcare infrastructure exposed to COVID-19: emerging risks resilience indicators interdependencies and international standards.
30972733 2019. Vaccines for emerging pathogens: prospects for licensure

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