The United States Food and Drug Administration Prescription Drugs

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

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

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

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

HHS Agenda Signals FDA’s Intent to Issue Proposed DSCSA Rules in December 2016

FDA intends to issue long-awaited proposed regulations governing the licensing of prescription drug wholesale distributors and third-party logistics providers (“3PLs”) this December, according to the updated 2016 HHS...more

OTC Drug Regulatory Paradigm Open to Stakeholder Feedback Until July 10

Continuing a discussion that began in 2014, on June 10, 2016 FDA hosted a public meeting on the potential development of a user fee program for OTC (over-the-counter, or nonprescription) drug products marketed pursuant to the...more

Samsung Bioepis Presents New Biosimilars Data at EULAR 2016

At the Annual European Congress on Rheumatology (EULAR 2016), held last week in London, Samsung Bioepis presented new clinical data on its etanercept, adalimumab, and infliximab biosimilars. According to a press release from...more

It’s Not The Same Old JPML

Back when we were first getting into the drug and device practice, a senior partner we know and trust told us that the JPML was “in the MDL business.” What did he mean by that? Well, that unique panel of federal judges never...more

FDA Issues Guidance on Expanded Access Use of Investigational Drugs

The U.S. Food and Drug Administration (FDA) issued three final guidance documents on June 2, 2016, that address FDA's rules and regulations governing "expanded access" to investigational drugs. The expanded access process –...more

FDA Has Extended the Comment Period For Its Draft Biosimilar Labeling Guidance

The FDA has extended the public comment period for its draft guidance “Labeling for Biosimilar Products: Guidance for Industry” by 60 days, to August 2, 2016...more

Generic vs. Branded Liability: Mensing Holds Sway Until FDA Completes Rulemaking

FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty. The U.S. Food and Drug Administration (FDA) recently announced it...more

The (suf)Fix is In: FDA Opens the Floor for Comments on Biologic Naming Guidance

On June 2, 2016, the FDA filed a notice for comments on guidance requesting that biologic applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name...more

FDA Announces Closer Ties to WHO on Biologics

On May 31, 2016, the FDA issued a notice that FDA’s Center for Biologics Evaluation and Research (FDA/CBER) intends to “enhance technical collaboration and cooperation between the FDA, WHO, and its member states to facilitate...more

Is Sponsor-Submitted Clinical Data Safe?

The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety,...more

Questions About FDA’s Drug Approval Process Answered

The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to...more

GPhA Responds to PhRMA/BIO’s Joint Citizen Petition Regarding Biosimilar Labeling

As we previously reported, in late 2015, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations jointly submitted a Citizen Petition asking the...more

Administration Releases Spring 2016 Regulatory Agenda with Timeline for Rulemaking

The Obama Administration has posted its updated 2016 regulatory agenda, which lists major pending or planned rulemaking and the expected timing for action. The latest agenda includes numerous rules in the pipeline impacting...more

FDA Accepts Samsung Bioepis’s BLA for Remicade® Biosimilar

Samsung Bioepis Co., Ltd., announced that the FDA has accepted its first biosimilar application submitted in the United States. The candidate, SB2, references Janssen’s Remicade® (infliximab), which treats several ailments,...more

USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On May 6, 2016, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule entitled, “Patient Protection and Affordable Care Act; Amendments to Special...more

Labeling and Pedigree Requirements of the Drug Supply Chain Security Act

Counterfeit and adulterated prescription drugs in the supply distribution chain pose a significant risk to patient safety. On November 27, 2013, President Obama enacted the Drug Supply Chain Security Act (DSCSA), which amends...more

Amarin Pharma Comes Out on Top in Federal Case Involving Freedom of Speech

The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional...more

Guest Post – Highlights of FDA Draft Guidance on 3D Printing

Another guest post today, this one by Reed Smith’s Matt Jacobson on the draft guidance document released earlier this week by the FDA. With the 3D printing of medical devices at the forefront of the burgeoning additive...more

Did drug maker fuel abuse by insisting that OxyContin works for 12 hours?

OxyContin in two decades not only has become a highly profitable, exceedingly popular prescription, it also has become one of the nation’s most abused painkillers-for a crucial reason, the Los Angeles Times says. The paper...more

Key Takeaways from FDA's New Guidance for Prescription Drug Compounders

On April 15, 2016, the Food and Drug Administration (FDA) released draft guidance that describes the FDA's interpretation of drug compounding standards under Sections 503A and 503B of the Food Drug & Cosmetic Act (FD&C Act)....more

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