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The Fixx: FDA Clarifies Distinctions Between Medical Device Servicing and Remanufacturing

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

Love Is Like Oxygen (Unless FDA Thinks You Get Too Much, You Get Too High): FDA Issues a Warning Letter to a Medical Device...

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

Harmony and Me: FDA Issues Final Rule to Amend Quality System Regulation for Medical Devices

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

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

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices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 In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more

Honesty is Hardly Ever Heard, And Mostly What FDA Needs From Your Firm: Handling a Regulatory Call or Meeting With FDA

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

There’s No Reply At All: It’s Never a Good Idea To Ignore FDA During an Inspection (and, in Fact, It’s Illegal)

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

AGG Food & Drug Newsletter - October 2021

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

AGG Food & Drug Newsletter - August 2021

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

I Can See Clearly Now: FDA Issues Final Guidance on the Form and Content of the Unique Device Identifier

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

AGG Food & Drug Newsletter - June 2021

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

See Me, Feel Me: FDA Gives Guidance on Remote Interactive Evaluations of Drug Facilities During COVID-19

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

Quality Agreements: An AGG Podcast Recap

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

AGG Food & Drug Newsletter - September 2020

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

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under... [Video]

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

Money, Money, Money . . . . It’s A Rich Man’s World: Getting Funding for COVID-19-Related Medical Products

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

FDA Issues Warning Letter for Unapproved Medical Device for Significant Product Quality and Corrective Action-Related Violations

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

It Is Not All About the Coronavirus Part 2: The CARES Act Brings Reforms to the Medical Device Industry

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

AGG Food & Drug Newsletter - November 2019

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

Attention Pharma Industry: Update your Drug Product Listings Now (FDA Will Begin to Deactivate Old and Outdated Listings Soon)

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

OPDP Sends Second Enforcement Letter of the Year

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

FDA Has Not Gone Away When It Comes to Unlawful Medical Device Promotion: Companies Receive Warning Letters for Violative...

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

Pharma Supply Chain Cornucopia: More FDA Guidance on DSCSA Product Identifier and Verification Requirements

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

FDA Releases an Internal Policy on Inspections (Selection of Drug Manufacturing Sites for Inspection)

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

FDA Launches Pilot to Expand the Special 510(k) Program

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

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