In September 2014, AGG prepared a Bulletin on the Food and Drug Administration’s Breakthrough Therapy Designation (BTD) program, referencing The Doors’ “Break On Through to the Other Side.” Time for Part 2. FDA issued a draft...more
States now have through March 31, 2025 to use the federal medical assistance percentage (FMAP) funding made available by the American Rescue Plan Act (ARPA). The announcement was made by the U.S. Department of Health and...more
Channeling Led Zeppelin’s “In Through The Out Door,” in May 2022, the Food and Drug Administration issued a guidance for industry entitled, “Importation of Prescription Drugs Final Rule Questions and Answers (Small Entity...more
Georgia assisted living communities and personal care homes will be eligible for up to $100,000 of grant funding to reimburse COVID-related expenses. Georgia Governor Brian P. Kemp announced he will award over $217 million...more
5/4/2022
/ American Rescue Plan Act of 2021 ,
Assisted Living Facilities (ALFs) ,
Change of Ownership ,
Coronavirus/COVID-19 ,
Federal Funding ,
Georgia ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Infectious Diseases ,
Long Term Care Facilities ,
Reasonable Prevention Procedures ,
Risk Mitigation
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
3/28/2022
/ 510(k) RTA ,
Cosmetics ,
FDA Warning Letters ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Investigational New Drug Application (IND) ,
Life Sciences ,
OPDP ,
Personal Care Products ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements
Continuing the theme of increased transparency of ownership of nursing homes included in the 2010 Affordable Care Act, the White House issued a Fact Sheet titled “Protecting Seniors and People with Disabilities by Improving...more
3/9/2022
/ Affordable Care Act ,
Assisted Living Facilities (ALFs) ,
Biden Administration ,
Business Ownership ,
Centers for Medicare & Medicaid Services (CMS) ,
Change in Ownership ,
Department of Health and Human Services (HHS) ,
Elder Care ,
Health and Safety ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Nursing Homes ,
Private Equity ,
REIT ,
Transparency
The Food and Drug Administration let sponsors and requestors of over-the-counter (“OTC”) monograph drugs know how to be in the room where it happens when it issued a draft guidance this month on “Formal Meetings Between FDA...more
3/2/2022
/ Biotechnology ,
CARES Act ,
Draft Guidance ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda
Illinois legislators are taking action to increase scrutiny of nursing home ownership. The disclosure provisions are included in the Compromise Nursing Home Rate Reform Bills (HB 4678)....more
In a nod to Alice Cooper’s 2000 song, “It’s the Little Things” (or, for literary fans, Robert Frost’s quote, “It’s the little details that are vital; little things make big things bigger”), the Food and Drug Administration’s...more
2/22/2022
/ Drug Distribution ,
Enforcement Actions ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Listing Standards ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Standards ,
Supply Chain ,
Warning Letters
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
2/1/2022
/ Advertising ,
Biden v Missouri ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Employer Mandates ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Workers ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
National Federation of Independent Business v Department of Labor and OSHA ,
OPDP ,
Opioid ,
OSHA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain ,
Vaccinations
Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more
1/26/2022
/ Business Disruption ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Notification Requirements ,
Pharmaceutical Industry ,
Public Health ,
Public Health Emergency ,
Regulatory Requirements ,
Supply Chain