The 1980s British rock band, The Fixx, comes to mind when one reads the Food and Drug Administration’s recently issued “Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug...more
One of the catchiest songs written by the 1970s British glam rock band, Sweet, is “Love Is Like Oxygen,” released in 1978. The chorus includes the lyrics, “Love is like oxygen; you get too much, you get too high.” Apparently,...more
In 1973, Sir Elton John sang, “Harmony and me, we’re pretty good company,” on his classic album, Goodbye Yellow Brick Road. More than 50 years later, the Food and Drug Administration issued a Final Rule to amend the medical...more
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
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 In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more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Draft Guidance ,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
From the 1978 52nd Street album, Billy Joel sings, “Honesty is such a lonely word, everyone is so untrue; honesty is hardly ever heard, and mostly what I need from you.” While we don’t want to start out this Bulletin on such...more
Rule Number One: If a facility is regulated by the Food and Drug Administration, the agency may inspect it (although there are some boundaries, not discussed here)....more
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
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
Channeling Johnny Nash and the 1972 classic song, “I Can See Clearly Now,” on July 7, 2021, the Food and Drug Administration issued its final guidance titled, “Unique Device Identification System: Form and Content of the...more
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
Channeling The Who’s Tommy Soundtrack and the classic song “See Me, Feel Me,” the Food and Drug Administration issued a guidance document, “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring...more
A few weeks ago, AGG’s Food and Drug Practice Team launched its podcast series to discuss topics affecting the FDA-regulated industry. The series, called “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues,”...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more
AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” Each month, we will release a new podcast where different members of our Food and Drug practice...more
While many of us are justifiably focused on the negative aspects of the COVID-19 pandemic, one positive result has been the way in which the life sciences community has answered the call to develop lifesaving medical...more
The Food and Drug Administration issued a Warning Letter to a medical device company after conducting an inspection of the facility’s medical device operations....more
President Donald Trump signed the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) into law on March 27, 2020, to help mitigate the economic effects of the Coronavirus Disease 2019 (COVID-19) pandemic....more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
FDA recently reminded pharmaceutical manufacturers and other registered drug establishments to confirm that all product listing records are current and to remove outdated listings. The agency will soon begin deactivating old...more
The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) recently sent an Untitled Letter to the manufacturer of a weight-loss drug for its Internet promotion. ...more
In April 2019, the Food and Drug Administration issued two Warning Letters to medical device manufacturers, reminding industry that the agency will take enforcement action against unlawful promotion when it sees fit. One...more
So far this Fall, the Food and Drug Administration (FDA) has issued four guidance documents regarding the product identifier and verification systems requirements of the Drug Supply Chain Security Act (DSCSA). ...more
The Food and Drug Administration (FDA) has released an internal policy related to risk-based scheduling and prioritization of surveillance inspections for drug manufacturing facilities. ...more
On October 1, 2018, the Food and Drug Administration (FDA) announced a pilot expansion of the Special 510(k) Program. The Special 510(k) Program was developed to help streamline the 510(k) premarket notification process for...more