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In Through the Out Door: FDA Issues Guidance on Its Importation of Prescription Drugs Final Rule

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 COVID-19 Prevention and Mitigation Assisted Living Communities and Personal Care Homes Grant To Provide $47 Million for...

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

AGG Food & Drug Newsletter - March 2022

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

What’s That Smell? California Safe Cosmetics Program Wants to Know

Channeling Lynyrd Skynyrd’s 1977 classic song, “That Smell,” on January 1, 2022, California Senate Bill 312 (SB 312), now known as the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (“CFFIRKA”), went into...more

Proposal Calls for Increased Transparency of Ownership for Privately Owned Nursing Homes

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

The Room Where It Happens: FDA Issues Draft Guidance on Formal Meetings Between FDA and Sponsors of OTC Monograph Drugs

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and requestors of over-the-counter (“OTC”) monograph drugs know how to be in the room where it happens when it issued a draft guidance this month on “Formal Meetings Between FDA...more

Illinois Bill Pushes Long-Term Care Operators to Reveal Ownership Interests

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

It's the Little Things: FDA Issues a Warning Letter for Improper Drug Listing

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

AGG Food & Drug Newsletter - January 2022

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

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

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

Upcoming Annual Deadline for HIPAA Small Breach Reporting: March 1, 2022

HIPAA-covered entities should note the quickly approaching March 1, 2022 deadline for reporting breaches of unsecured protected health information that occurred in 2021 and involved fewer than 500 individuals. This article...more

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