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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

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

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

Some May Come and Some May Go: FDARA Brings Changes to User Fees and Other FDA Programs

On August 18, 2017, the President signed the FDA Reauthorization Act of 2017 (FDARA), which revises and extends several of FDA’s user fee programs. The user fee programs establish filing fees for various application types and...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

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

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

AGG Food and Drug Newsletter - April 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

4/14/2017  /  HHS , HIPAA , ITSR , OCR

Right-to-Try or Right to Ask?

Recently, the American Society of Clinical Oncology (ASCO), a prominent medical organization, announced that it does not support so called “right-to-try” laws. Right-to-try legislation, which has now gained support in 33...more

Antitrust Exemption for Health Insurance Companies May Come to a Close

Recently, the House of Representatives voted to pass H.R. 372, also known as the Competitive Health Insurance Reform Act of 2017, which would close the longstanding antitrust immunity granted to health insurance companies....more

AGG Food and Drug Newsletter - March 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 the Sunshine In: Increased Transparency Coming to FDA Advisory Committees

Spurred by a challenge from Public Citizen last year, the Food and Drug Administration announced recently that it will no longer redact information from the curricula vitae (CV) of advisory committee members. Current advisory...more

3/15/2017  /  Advisory Committee , FDA , Transparency

AGG Food and Drug Newsletter - February 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

FDA Says Sharing Medical Product Information is Caring, to an Extent

FDA recently issued a draft guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers”, which is intended to bring clarity to a specific provision in...more

AGG Food and Drug Newsletter - January 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

DOJ and SEC Close Out 2016 with a $520 Million FCPA Settlement

The Securities and Exchange Commission (SEC) and Department of Justice (DOJ) wrapped up 2016 on December 22 with a near record-breaking Foreign Corrupt Practices Act (FCPA) settlement involving Teva Pharmaceuticals and its...more

Expansion of the Humanitarian Use Device Program under the 21st Century Cures Act

The 21st Century Cures Act, signed into law in December 2016, ushered in a number of changes that will affect the Food and Drug Administration’s product development programs. One such example relates to the expansion of the...more

FDA Issues Draft Guidance on 510(k) Third Party Review Program

The Center for Devices and Radiological Health (CDRH) recently issued a draft guidance on the 510(k) Third Party (TP) Review Program. The TP Review Program (formerly known as the Accredited Persons Program) allows FDA to...more

AGG Food and Drug Newsletter - December 2016

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

Thanks to 21st Century Cures, the Sun is Coming out Tomorrow for Orphan Drugs and Pediatric Priority Review Vouchers

The 21st Century Cures Act, a bill that includes major Food and Drug Administration reform, was passed by the Senate last week and was signed by President Obama on Tuesday, December 13, 2016. While the new law addresses a...more

21st Century Cures Act Brings New Research Funding and Changes to the FDA

Last week the Senate passed, nearly unanimously, the 21st Century Cures Act, which President Obama signed on December 13, 2016. The Act is divided into three divisions: 21st Century Cures, Helping Families in Mental Health...more

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