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Unlocking the mRNA Platform Technology: Walking the Talk with Investment Protection

Bill of Health

However, rewards from these government investments are going back into the hands of pharma corporations and shareholders, with little thought given to public needs. Recent Research on Public Funding of mRNA Technology The first of the two new articles is an in-depth empirical study of U.S.

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Key Legal Issues Facing Telehealth Platforms, as Compliance Concerns Bubble for Platforms Launched During the Public Health Emergency

Health Care Law Brief

The onset of the COVID-19 public health emergency (“PHE”) led to a surge in the use of telehealth by health care providers. Variety of Risks Present in Telehealth Arrangements. The severity and type of risk present in a telehealth business will vary—by jurisdiction, by provider type, by service offering, and by payor mix.

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SQA Regulatory Surveillance Summary 2 | Monthly Update 2021

SQA

The concepts presented in PDA Technical Report No. United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing SARS-CoV-2 Virus Variants, 22 February 2021.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”

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States and Feds Signal Big Changes to Telehealth Prescribing

Health Law Advisor

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing. [1]

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

ANVISA Warns of New Cases of Botulinum Toxin Counterfeiting, 05 April 2023 ANVISA alerts health professionals and the population to the fact that new cases of adulteration/falsification of the drug Botox® 100U (botulinum toxin A), Batch Number C6835C3 have been identified. It addition, the company did not report one or more recalls.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

The EC presented a first draft for public comment to the revision of Annex 1 in 2017. More than 6,000 comments led, quite unusually, to a second draft for renewed public comment in 2020. United States Food and Drug Administration (FDA) – Regulations and guidance.

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