J. Mark Ray

J. Mark Ray

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Alston & Bird Health Care Week in Review - February 2022 #2

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

2/15/2022  /  Centers for Disease Control and Prevention (CDC) , Congressional Investigations & Hearings , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Draft Guidance , Food and Drug Administration (FDA) , GAO , Health Care Providers , Information Reports , National Institute of Health (NIH) , Pharmaceutical Industry , Popular , Request For Information , SAMHSA , Vaccinations

Alston & Bird Healthcare Week in Review - February 2020 #2

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

2/18/2020  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , GAO , Pharmacy Benefit Manager (PBM)

Alston & Bird Healthcare Week in Review

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

12/16/2019  /  Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , FDA Reauthorization Act , Food and Drug Administration (FDA) , GAO , Health Care Providers , Pharmaceutical Industry

Alston & Bird Healthcare Week in Review

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

9/9/2019  /  Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Children's Health Insurance Program (CHIP) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Healthcare , HRSA , Pharmaceutical Industry

Alston & Bird Healthcare Week in Review

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

8/19/2019  /  Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , HRSA , Medicare Part D , Pharmaceutical Industry , Pharmacy Benefit Manager (PBM) , SAMHSA

Alston & Bird Healthcare Week in Review

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

8/12/2019  /  Biologics , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , OMB , Pharmaceutical Industry

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

5/28/2019  /  Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , OCR , Opioid , Prescription Drugs

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

4/8/2019  /  Centers for Medicare & Medicaid Services (CMS) , CLIA , Clinical Laboratories , Food and Drug Administration (FDA) , GAO , Medicare Part D

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

3/25/2019  /  Children's Health Insurance Program (CHIP) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Medicaid , Medicare , Medicare Part D , OIG

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

3/11/2019  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , MACPAC , Pharmaceutical Industry , Prescription Drugs

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

2/25/2019  /  Abbreviated New Drug Application (ANDA) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Health Care Providers , HRSA , Pharmaceutical Industry , Prescription Drugs , SAMHSA

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

2/4/2019  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Health Care Providers , Medicare Part D , Pharmacy Benefit Manager (PBM) , SAMHSA

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

10/22/2018  /  Advertising , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , GAO , Pharmaceutical Industry , Prescription Drugs , Television Commercials

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

9/10/2018  /  Centers for Disease Control and Prevention (CDC) , Draft Guidance , Food and Drug Administration (FDA) , GAO , HRSA , MedPAC , Opioid

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

8/27/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Health Care Providers , Healthcare Fraud , HRSA , Inpatient Prospective Payment System (IPPS) , Medicare , OIG

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

7/23/2018  /  Abbreviated New Drug Application (ANDA) , Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Labeling , Medicare , Pharmaceutical Industry , SAMHSA , Section 340B

Alston & Bird Healthcare Week in Review

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

5/21/2018  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Generic Drugs , HRSA , Institutional Review Board (IRB) , Pharmaceutical Industry , Section 340B

Alston & Bird Healthcare Week In Review

I. Regulations, Notices, & Guidance - On February 12, 2018, the Food and Drug Administration (FDA) issued a guidance entitled, Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and...more

2/20/2018  /  Centers for Disease Control and Prevention (CDC) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , Health Care Providers , HRSA , Inpatient Prospective Payment System (IPPS) , OIG , SAMHSA

Alston & Bird Healthcare Week In Review

On January 16, 2018, the Food and Drug Administration (FDA) issued a proposed rule entitled, Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and...more

1/23/2018  /  Centers for Disease Control and Prevention (CDC) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , HRSA , Inpatient Prospective Payment System (IPPS) , Medicare , OCR , REMS , SAMHSA

Alston & Bird Healthcare Week in Review

On December 11, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements. The guidance clarifies the requirements for...more

12/19/2017  /  Ambulatory Surgery Centers , Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Children's Health Insurance Program (CHIP) , Department of Health and Human Services (HHS) , Draft Guidance , Food and Drug Administration (FDA) , GAO , Health Care Providers , Inpatient Prospective Payment System (IPPS) , Medical Devices , OPDP , OPPS , Physicians , REMS

A&B Healthcare Week in Review

On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more

1/31/2017  /  Affordable Care Act , Biologics , Centers for Medicare & Medicaid Services (CMS) , CGMP , Comment Period , Department of Veterans Affairs , DSCSA , Employer Payment Plans , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , GAO , Home Health Agencies , Manufacturers , Over-the-Counter Sales

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On May 6, 2016, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule entitled, “Patient Protection and Affordable Care Act; Amendments to Special...more

5/18/2016  /  Affordable Care Act , Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , GAO , Managed Care Contracts , Medicare , Medicare Advantage , Medicare Part D , Pharmaceutical Industry , Prescription Drugs , PTAC

A&B Healthcare Week in Review, November 2015

I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more

11/25/2015  /  Affordable Care Act , Biosimilars , CCIIO , Centers for Medicare & Medicaid Services (CMS) , Congressional Budget Office , Food and Drug Administration (FDA) , GAO , Healthcare , HELP , HRSA , Legislative Agendas , Medicaid , Physician-Owned Distributors , Prescription Drugs , Provider Payments , Veterans
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