Latest Publications

Share:

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

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

Money for Nothin': FDA's PDUFA Fee Waivers and Exemptions

Lately, we have received a number of client inquiries about prescription user fee waivers. The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes FDA to collect fees from companies that produce certain human...more

Things That Make You Go Hmmm, Part II: Drug Company Plays Games With FDA To Delay Facility Inspection

More than ten years ago, I wrote an article about a company action that invoked a memory of my then-3-year old son’s playful “The Thinker” pose. (I continue to have this picture hanging in my office now.) He would frequently...more

Doctor, Doctor, Give Me the News, I’ve Got a Bad Case of Medical App Blues: Mobile Medical Application Developers Settle with New...

The New York Office of the Attorney General recently announced settlements with developers of three mobile health applications due to misleading claims and deficient privacy practices. As a result of these settlements, 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

I’m Not Dead (Yet): FDA Continues to Enforce Unlawful Product Promotion

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

Arizona Enacts Law Permitting Off-Label Promotion

As we have previously covered, the Food and Drug Administration is in the midst of reevaluating its policy on off-label promotion of medical products—that is, promotion of drugs, medical devices, and biologics for uses not...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

FDA Is Cold As Ice As It Steps Up Foreign Inspection Enforcement

So far, in 2017, the Food and Drug Administration’s Office of Manufacturing Quality in the Center for Drug Evaluation and Research has released fourteen Warning Letters. Of these, 100% involved manufacturing facilities...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

Anyone Can Enter Into a Quality Agreement, It's the Hold: FDA Issues a Warning Letter Referencing Lack of Quality Oversight

Many of us remember the classic comedy bit on the Seinfeld television show where Jerry was unable to secure the rental car for which he had made a reservation. He tells the agent: See, you know how to ‘take’ the...more

2/8/2017  /  CGMP , FDA , Manufacturers , Warning Letters

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

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information...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

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

Happy Holidays from FDA: The Agency Issues Four Enforcement Letters for Unlawful Promotion

The Food and Drug Administration recently issued holiday gifts, in the form of enforcement letters, to four pharmaceutical companies. The letters are reminders that FDA is not in a partying mood when it comes to unlawful...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

Come on People Now ... Everybody Get Together, Try to Love One Another: FDA Issues Final Guidance on Quality Agreements

Three and a half years after issuing its draft guidance, on November 22, 2016, the Food and Drug Administration released its final guidance, “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance is...more

Show Me, Show Me, Show Me: FDA to Post Adverse Event Report Data Associated With Certain Products

On December 7, 2016, the Food and Drug Administration announced that it would post on its website adverse event reports from January 2004 to the present for food (including food additives, color additives, and dietary...more

AGG Food and Drug Newsletter - October 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

69 Results
/
View per page
Page: of 3

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.