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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

Spelling Counts (Among Other Things): FDA Issues Warning Letters for Mistakes in Drug Listing

Recently, the Food and Drug Administration issued two Warning Letters to pharmaceutical companies for failing to fulfill product listing obligations for what appear to be oversights. In the first letter issued at the end of...more

FDA Says Viewers Catch a Fleeting Glimpse; Can’t Hear What You’re Saying to Sponsor of Ad with Mismatched Audio and Visual Risk...

Recently, FDA’s Office of Prescription Drug Promotion (OPDP) issued its first Untitled Letter of the year, citing a direct-to-consumer TV advertisement for a prescription weight- loss drug. According to OPDP, the ad made...more

When FDA Says, “It Ain’t Good Enough” – Rare Litigation over Pediatric Exclusivity

Well, the other Boss, Bruce Springsteen, not FDA, used those words. When FDA said essentially the same thing less lyrically, but with better grammar, Amgen initiated a lawsuit on May 25, 2017, over an infrequently litigated...more

AGG Food and Drug Newsletter - May 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

Let’s Get Clinical: ClinicalTrials.gov Reporting Requirements Now in Effect

The compliance date for the Final Rule implementing the clinical trial reporting requirements of Section 801 of the Food and Drug Administration Amendments Act (FDAAA), also known as FDAAA 801, arrived on April 18, 2017. The...more

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