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 colleagues in other related life science disciplines.

In This Issue

• Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug
• Get Back to Where You Once Belonged: FDA Issues Final Guidance on Initiating Voluntary Recall
• Roll With the Changes: FDA’s Proposed Amendments to Converge Its Quality Management System Requirements With ISO Requirement
• Don’t Go Changing . . . Unless You Ask FDA
• The Room Where It Happens: FDA Issues Draft Guidance on Formal Meetings Between FDA and Sponsors of OTC Monograph Drugs
• It's the Little Things: FDA Issues a Warning Letter for Improper Drug Listing
• What’s That Smell? California Safe Cosmetics Program Wants to Know

Industry Insights

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug
By Alan G. Minsk and Laura S. Dona

In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug Administration “feeling groovy.” The Food and Drug Administration’s Office of Prescription Drug Promotion issued a Warning Letter to the drug company for promoting an investigational new drug.

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Get Back to Where You Once Belonged: FDA Issues Final Guidance on Initiating Voluntary Recall
By Alan G. Minsk and Robert Durkin

In 1969, The Beatles told Jo Jo and Loretta to “get back to where you once belonged.” In 2021, we could view a documentary series by the same name about the recording sessions behind the classic Let It Be album. FDA officials might have watched the series (or are familiar with the song) because, this month, it issued a final guidance for industry and FDA staff called “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.” FDA issued a draft guidance with the same title on April 24, 2019. In addition to editorial changes, the final guidance includes language that promotes the use of electronic communications when conducting a recall of FDA-regulated products.

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Roll With the Changes: FDA’s Proposed Amendments to Converge Its Quality Management System Requirements With ISO Requirements
By Alan G. Minsk and Laura S. Dona

In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice Advisory Panel met to discuss a Proposed Rule designed to harmonize FDA’s Quality System Regulations (“QSRs”) with the International Organization for Standardization 13485:2016 (“ISO 13485” or “ISO 13485:2016”) requirements.

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Don’t Go Changing . . . Unless You Ask FDA
By Alan G. Minsk and Laura S. Dona

The Food and Drug Administration recently issued a Warning Letter to a medical device manufacturer for making significant changes to its 510(k)-cleared products for uses outside the scope of the 510(k) clearance, among other reasons. While the Warning Letter focused more on quality-related issues, it is a reminder that the agency continues to monitor products that might require a new 510(k) and will take enforcement action as needed.

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The Room Where It Happens: FDA Issues Draft Guidance on Formal Meetings Between FDA and Sponsors of OTC Monograph Drugs
By Alan G. Minsk and Kadeja A. Watts

In the original Broadway show Hamilton, Leslie Odom, Jr. sang, “I want to be in the room where it happens.” 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 and Sponsors or Requestors of Over-the-Counter Monograph Drugs.”

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It's the Little Things: FDA Issues a Warning Letter for Improper Drug Listing
By Alan G. Minsk and Kadeja A. Watts

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 Center for Drug Evaluation and Research issued a Warning Letter to a drug company for improper drug listing information.

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What’s That Smell? California Safe Cosmetics Program Wants to Know
By Alan G. Minsk and Kadeja A. Watts

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 effect. CFFIRKA requires companies that sell cosmetic or personal care products that contain reportable fragrance and flavor ingredients included in CFFIRKA to report such information to the California Safe Cosmetics Program (“CSCP”), which is a part of the California Department of Public Health, Division of Environmental and Occupational Disease Control.

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