The United States Food and Drug Administration

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

Picture of Health: FDA Rule Allows Symbols to Replace Text on Device Labels

In June 2016, the U.S. Food and Drug Administration (FDA) issued its final rule explicitly allowing the use of approved symbols, without accompanying text, on medical device and certain biological product labeling. The FDA...more

FDA’s Expedited Access Program: A Year in Review

A new blog post by The Food and Drug Administration (FDA) published earlier this month provides an update regarding the implementation of the year-old Expedited Access Pathway (EAP) program, which was created in April 2015 by...more

Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more

The CREATE Act of 2016: Senate Listens to Generics Industry

Last week, co-sponsors Senators Leahy (D-VT), Grassley (R-IA), Klobucher (D-MN), and Lee (R-UT) introduced a bill (S. 3056), entitled the "Creating and Restoring Equal Access to Equivalent Samples Act of 2016" or the "CREATES...more

For congressional overseers, red flags fly over issues at FDA

Congressional overseers of the federal agency that regulates drugs and medical devices have gotten red-flag warnings about problems at the Food and Drug Administration, including: two separate calls for improvements from...more

How Americans Eat: Unveiling of the New Nutrition Facts Label

Over a decade in the making, the U.S. Food and Drug Administration (“FDA” or the “Agency”) recently issued two final rules revising its nutrition labeling regulations, most notably, the Nutrition Facts label. The revisions...more

FDA Withdraws Previous Notice Seeking Comments on Proposed Biologic Naming Guidance

Earlier this month we reported that FDA had published a notice in the Federal Register soliciting comments on a proposed biologic naming guidance whereby applicants for biologic products would submit up to 10 proposed...more

Connecticut's New "Right to Try" Law Provides Hope for Patients and Providers, but FDA Remains in the Driver's Seat

Connecticut has recently joined the wave of states enacting a so-called “Right to Try” law, which ostensibly permits terminally ill patients access to investigational drugs (including biologics) and medical devices as a...more

FDA Releases Draft Guidance for Manufacturers on Dissemination of Patient Data from Medical Devices

On June 9, 2016, the US Food and Drug Administration (FDA) published draft guidance outlining considerations for the “appropriate and responsible” dissemination of individualized medical device data from device manufacturers...more

Why the FDA Needs to Change Its Food Recall Policies

Add this to FDA’s growing list of things to do: improve the food recall initiation process. According to a memorandum published on June 8, 2016, the Office of Inspector General (OIG) of the Department of Health and Human...more

Amgen v. Sandoz SCOTUS Appeal on Hold Until October

The Supreme Court on Monday called for the views of the Solicitor General regarding the petitions for certiorari filed by both parties in Amgen v. Sandoz. The case arose after Sandoz filed an aBLA for Zarxio®, a biosimilar of...more

Can Plaintiffs Sue a “Celebrity Spokesperson”?

We’ve thought a lot about the various secondary entities that plaintiffs sometimes sue in prescription medical product liability litigation – such as sales reps, physicians, hospitals, pharmacies, distributors, and a number...more

FDA Issues Interim Response to PhRMA/BIO Joint Citizen Petition on Biosimilar Labeling

As we previously reported, late last year the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) trade associations jointly submitted a Citizen Petition asking the FDA...more

Supreme Court asks SG for views on Sandoz, Amgen petitions: Analysis and Next Steps

As we posted on June 20, the Supreme Court has invited the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari. Below we provide further analysis and commentary on the...more

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of...more

Orlando shootings raise health care concerns

Here’s hoping that the mass shooting in Orlando will focus attention on some health care issues that the event flushed into open view: Gay activists and others have denounced anew these restrictions. They say these rules...more

AGG Food and Drug Newsletter - June 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

FDA New-trition Rules

Last month, the FDA finalized amendments to the Nutrition Facts labeling rules for packaged foods and dietary supplements to reflect developments in nutrition science, including new scientific information regarding the link...more

The Last Set of Major FSMA Regulations Are Done!

The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency...more

FDA Streamlines the Expanded Access Approval Process for Individual Patients

The U.S. Food and Drug Administration (FDA) just made it easier for physicians to get critically needed, but not yet approved in the U.S., treatments to some of the nation’s most critically ill patients. FDA Commissioner...more

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices by Device Manufacturers

On June 10, 2016, the Food and Drug Administration issued a draft guidance for industry and agency staff entitled, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers.” FDA will accept comments...more

The First Cut is the Deepest: FDA Issues a Warning Letter to a Skincare Company for Marketing Unapproved New Drugs

The Food and Drug Administration recently issued a Warning Letter to a skincare company for promoting and selling unapproved new drugs. While the letter itself is not unusual in content, the enforcement action continues a...more

News from Second and State

The laws of physics tell us that objects in motion tend to stay in motion, and that rule held true for the Pennsylvania General Assembly this week. Carrying over from the hustle and bustle of last week, we saw plenty of...more

A Symbolic Victory? FDA's Final Rule On Stand-Alone Symbols In Medical Device Labeling Raises Important Litigation Risk Questions

FDA this week released a final rule that will undoubtedly raise new litigation questions for medical device manufacturers in the context of product liability claims. The final rule, for the first time, permits medical device...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

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