SQA

OCTOBER 18, 2024

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

FDA 52

FDA Compliance Public Health World Health 52

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

SQA

FEBRUARY 26, 2024

The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. In Australia, medicines and chemicals are classified into schedules according to the level of regulatory control required to protect public health and safety.

FDA 52

FDA Compliance COVID-19 Public Health 52

SQA

OCTOBER 18, 2024

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

FDA 40

FDA Compliance Public Health Governance 40

SQA

FEBRUARY 26, 2024

The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. In Australia, medicines and chemicals are classified into schedules according to the level of regulatory control required to protect public health and safety.

FDA 40

FDA Compliance COVID-19 Public Health 40

SQA

DECEMBER 16, 2022

26 of 2014. It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities. Issuance of a device filing number via a “Notification of Filing Number,” which replaces the current Filing Certificate.

FDA 40

FDA Compliance COVID-19 Licensing 40

Health Law Advisor

AUGUST 10, 2023

FDA specifically identified the following as not having to register as device manufacturers: Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice. [8] 8] We could go on, but hopefully you get the gist.

FDA 98

FDA Licensing Hospitals Medicaid 98

Hall Render

SEPTEMBER 22, 2023

So far, Georgia has only one Bull Realty Brokers $5.9M healthcare centers receive $935K in federal funding to provide free COVID-19 vaccines New CEO at Mt. 30 deadline Oregon hospital leader Becky Hultberg talks unions, finances and emerging from COVID Oregon passed a historic nurse staffing law.

COVID-19 40

COVID-19 Nursing Homes COVID-19 Vaccine Nurses 40

Healthcare Law Blog

JANUARY 10, 2022

Entering the third year of the COVID-19 public health emergency, CMS seeks to clarify the period of time during which MAOs must comply with the special requirements at 42 CFR 422.100(m) to ensure access for enrollees to covered services throughout the disaster or emergency period.

Medicare 98

Medicare Medicare COVID-19 Medicaid 98

Hall Render

APRIL 1, 2022

Coalition of hospitals, health plans and others urge for stronger guidance around third-party apps. Hospital, long-term care groups again petition Becerra to extend COVID-19 public health emergency. Rural Alabama wastewater infrastructure ‘public health issue’ gets much-needed attention.

COVID-19 40

COVID-19 US Department of Health and Human Services Nursing Homes Nurses 40

Health Populi

JANUARY 5, 2021

When he led Turing Pharmaceuticals in 2015, he acquired a license for the drug Daraprim (an anti-malarial therapy also used for HIV/AIDS), raising the drug price from $13.50 Among the ten awards, I’ve selected three to highlight to synthesize one systemic issue that has plagued America’s response to the public health crisis.

COVID-19 62

COVID-19 COVID-19 Vaccine Public Health Doctors 62

Drug & Device Law

FEBRUARY 29, 2024

Through the PREP Act, Congress hoped to facilitate the quick deployment of crucial medical resources during public health emergencies, in part by freeing “covered person[s]” from the threat of civil litigation and liability. A Primer on the PREP Act. 247d-6d(a)(2)(B). See Retail Prop. United Bhd. of Carpenters & Joiners of Am.,

COVID-19 59

COVID-19 Informed Consent FDA Governance 59