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Homeopathic Regulation Has Come to Stay

FDA closed out 2017 with a brief, but long-awaited, draft guidance on Drug Products Labeled as Homeopathic (Homeopathic Guidance), which lays out FDA’s new regulatory strategy for these products. Under the Federal Food, Drug,...more

Don’t Forget Your FDA Valentine

In addition to reauthorizing various user fee programs, the FDA Reauthorization Act of 2017 (FDARA), which was enacted last summer, added a one-time marketing status reporting requirement for holders of new drug applications...more

AGG Food and Drug Newsletter - November 2017

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

How to Pay the Piper: FDA Issues New Guidances for PDUFA VI and GDUFA II

FDA recently issued two draft guidances: Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (GDUFA II), which...more

FDA Issues Guidance on Submitting 510(k)s for Changes to Existing Devices

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

FDA Issues Guidance on Drug and Device Classifications

On September 26, 2017, the Food and Drug Administration (FDA) announced the availability of a final guidance entitled Classification of Products as Drugs and Devices & Additional Product Classification Issues to clarify FDA’s...more

Recent Developments on the Opioid Front

The “Opioid Crisis” continues to drive measures that will significantly affect the pharmaceutical industry in general, the relationship between prescribers and their patients, and the role of regulators – and law enforcement...more

AGG Food and Drug Newsletter - October 2017

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

Here, There, and Everywhere: Opioid Manufacturers and Distributors Under a Brighter Spotlight

In June 2017, a bipartisan group of state attorneys general announced that they were jointly investigating the marketing and sales practices of opioid manufacturers. While the group initially did not identify any targets of...more

These Flakes Can’t Fake it – FDA Says They’re Not Medical Foods

FDA recently issued a warning letter to a medical food manufacturer for several violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The violations were discovered during FDA’s inspection of the facility. FDA said...more

AGG Food and Drug Newsletter - September 2017

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

Recent Warning Letters from FDA about Medical Devices: Investigational Device Exemptions and Lack of Marketing Authorization are...

Over the past several months, the Food and Drug Administration (FDA) has issued several Warning Letters related to Investigational Device Exemption (IDE) requirements and misbranding. An IDE allows an investigational device...more

FDA Issues Guidance on Use of Real-World Evidence for Medical Devices

On August 31, 2017, the Food and Drug Aministration issued a final guidance titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” In the guidance, which finalizes the agency’s July...more

The Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and...

On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization....more

A Rose by Any Other Name: Drug Claims Make Your Cosmetic a Drug

Last month, FDA district offices issued Warning Letters to two cosmetic companies for making claims that established their products as drugs. In finding that the products were new drugs requiring premarket approval, FDA...more

8/18/2017  /  Cosmetics , FDA , Manufacturers , Warning Labels

AGG Food and Drug Newsletter - August 2017

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

Sign, Sign, Everywhere A Sign: Don’t Overlook What FDA Says and Writes

In the 1971 song, “Signs,” the Canadian rock band, Five Man Electrical Band sang, “Sign, Sign, Everywhere a Sign … Can’t You Read the Sign?” The lyric resonates with us periodically as we discuss with a client a response from...more

Thank You Very Much, Mr. Roboto: FDA Announces New Digital Health Programs

Scott Gottlieb, M.D., FDA's commissioner, recently announced new digital health initiatives that will aid in the agency's push to regulate and support digital healthcare in the medical device space. In a statement posted to...more

Lawyers, Drugs, and Money – The Opioid Crisis Makes for Strange Bedfellows

It seems that almost every day there is a new development in the government’s response to the opioid crisis or opioid emergency. But it’s not only the government and healthcare providers that are considering novel approaches....more

Department of Justice Pilot Program Will Focus on Opioid Fraud and Abuse

On August 2, 2017, Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit and a new Department of Justice (DOJ) data analytics program to combat opioid-related fraud and abuse. The...more

AGG Food and Drug Newsletter - July 2017

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

You're Always a Day Away: DSCSA Product Identifier Requirements Delayed

In recently issued draft guidance related to the implementation of product identifiers under the Drug Supply Chain Security Act ("DSCSA"), FDA has stated that it intends to exercise enforcement discretion for a period of one...more

FDA Adds Additional Premarket Notification 510(k) Submission Requirements for Certain Reusable Medical Devices

The 21st Century Cures Act included a provision requiring the Food and Drug Administration (FDA) to publish a notice in the Federal Register identifying a list of reusable devices that will be required to include validated...more

A Meeting, a MaPP, and Two Lists: Initial Elements of the Commissioner’s Drug Competition Action Plan Rolled Out

FDA has been busy recently in areas tied to drug pricing. In the last half of June, FDA issued a public meeting notice, a revised Manual of Policy and Procedures (MaPP), and two lists of approved drugs for which a generic has...more

AGG Food and Drug Newsletter - June 2017

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

6/19/2017  /  FDA , HHS , HIPAA , OCR , PHI , Prescription Drugs , Warning Letters
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