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
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
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...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
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
On December 30, 2019, the Food and Drug Administration issued a final order that exempts certain class I and class II medical devices from 510(k) premarket review, subject to certain limitations....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
In September, the U.S. Food and Drug Administration issued multiple final guidance documents related to the medical device program. ...more
On September 9, 2019, the Food and Drug Administration released a final guidance document, Acceptance Review for De Novo Classification Requests, to clarify the content that companies need to include in de novo requests to...more
In 2018, the Food and Drug Administration announced several actions relevant to the 510(k) premarket notification regulatory pathway. AGG has previously written about some of these, such as the pilot expansion of the Special...more
In December 2018, the Food and Drug Administration issued a proposed rule that would amend the medical device classification regulation to implement the De Novo classification process. ...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
The Food and Drug Administration channeled, in the other direction, the 1979 Supertramp song, “Take the Long Way Home,” after it issued a draft guidance entitled, “Expansion of the Abbreviated 510(k) Program: Demonstrating...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
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
On October 25, 2017, the Food and Drug Administration (FDA) issued a final guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, which describes when a change in a medical device would...more
Many of us remember the classic bit in the epic 1975 Monty Python and the Holy Grail movie, where the Dead Collector asks the pestilence-infested community to bring out its dead, and one hapless individual calls out, “I’m not...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
Much has been written, including by us, about the Food and Drug Administration’s enforcement approach (or lack thereof) concerning off-label promotion. However, FDA has not curled itself up into a ball, abdicating its...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
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
8/23/2016
/ 510(k) RTA ,
Advertising ,
Draft Guidance ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
LabMD ,
Medical Devices ,
Pharmaceutical Industry ,
Social Media ,
Software
On the same day the Food and Drug Administration issued its revised draft guidance document on when to submit a new 510(k) premarket notification for an existing medical device, it released a similar document specific to...more
Many of us remember the classic 1972 Brady Bunch song, “Time to Change,” when Peter Brady sings (as his voice cracks), “When It’s Time to Change, You’ve Got to Rearrange,” channeling its inner Brady, the Food and Drug...more
Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and...more
8/27/2015
/ 510(k) RTA ,
Bifurcation ,
Commercial Speech ,
Data Security ,
Evidence ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Free Speech ,
Litigation Hold ,
Medical Devices ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Privacy Policy ,
Sanctions