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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 -

In Rare Decision, PTAB Grants Request for Rehearing, Reverses its Prior Decision, and Institutes IPR

Requests for rehearing at the Patent Trial and Appeal Board (the “Board”) are not uncommon; however, the Board rarely grants them. One reason for this result is the high standard applied to reverse a prior decision—abuse of...more

National Right to Try Act Passes U.S. House

by Thompson Coburn LLP on

The concept of a “Right to Try” has been spreading through the U.S. over the last four years, beginning with the first passing of such laws in Colorado in 2014. Most recently, President Trump has echoed support for a federal...more

FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

by Hogan Lovells on

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological products in some circumstances and...more

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

by Hogan Lovells on

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the historically underutilized...more

Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry

In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance. Only 33...more

FDA Seeks Comments On Potential Marijuana Reclassification Under International Drug Control Treaty

by Jackson Lewis P.C. on

The Food and Drug Administration requested comments in a notice published in the Federal Register on April 9, 2018 concerning the “abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling...more

(Don’t) Take the Long Way Home: FDA Issues Draft Guidance on Expansion of the Abbreviated 510(k) Program

by Arnall Golden Gregory LLP on

The Food and Drug Administration channeled, in the other direction, the 1979 Supertramp song, “Take the Long Way Home,” after it issued a draft guidance entitled, “Expansion of the Abbreviated 510(k) Program: Demonstrating...more

FDA Announces Plans to Improve Safety and Advance Innovation of Medical Devices

by Reed Smith on

On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan), which aims to support and advance innovation in medical devices while also...more

Filing Review is About More Than Checking the Boxes; or Is It?

by Arnall Golden Gregory LLP on

Things sometimes change fast. Our original article described one company’s recent announcement that the Food and Drug Administration refused to file its new drug application as a reminder that the agency’s filing review may...more

FDA Announces “Unique” Restriction on Approved Medical Device

by Arnall Golden Gregory LLP on

On April 9, 2018, the Food and Drug Administration announced an additional “unique type of restriction” on the sale and distribution of an approved medical device. FDA issued an order requiring healthcare providers and...more

The Legality of Cannabidiol and Concerns Regarding False Advertising

by Cozen O'Connor on

The legality of marijuana (also known as cannabis) has been a popular topic in recent years with thirty states and the District of Columbia having laws that legalize marijuana in some form. However, under federal law,...more

Wrap-Up of Federal and State Chemical Regulatory Developments, April 2018

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/TRI - EPA Issues Draft Guidance On Expanded Access To Confidential Business Information: On March 16, 2018, the U.S. Environmental Protection Agency (EPA) released three draft guidance documents for public...more

FDA Delays Enforcement of the Postmarketing Safety Reporting (PMSR) Final Rule

by Arnall Golden Gregory LLP on

The Food and Drug Administration issued a final rule setting forth postmarketing safety reporting (PMSR) requirements for combination products subject to premarket review by FDA on December 20, 2016. For some of these...more

Fresh From the Bench: Latest Federal Circuit Court Cases

In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more

Grapegrowing and FSMA Compliance

As of 2018, winegrape growers are now required to adhere to the burdensome requirements of the Food Safety Modernization Act (FSMA) Produce Safety Rule when selling winegrapes to wineries for processing. However, most...more

Here’s the Recipe: How to Ensure Your Food and Beverage Company Will Be Ready for a Value-Maximizing Sale

by Morrison & Foerster LLP on

You’ve created a great product and built a valued brand. You’ve devoted countless hours to building relationships with key distributors and retailers, designing attractive packaging, and forging a social media presence. But...more

What To Prepare For Dinner At Home - A Salad? An Omelet? Maybe Not When E. Coli & Salmonella Is At Risk

by Selman Breitman LLP on

Two East Coast Companies Announce Food Recalls - Thinking about fixing a salad at home today using that ready-to-eat salad mix you bought at the grocery store? If so, and you live in Indiana, Ohio, Pennsylvania or West...more

Capitol Hill Healthcare Update

by BakerHostetler on

HOUSE PANEL TO QUESTION GOTTLIEB ON FDA BUDGET - Food and Drug Administration (FDA) Commissioner Scott Gottlieb will testify Tuesday before a House appropriations subcommittee on his agency’s fiscal 2019 budget – which...more

Report Details Uneven Implementation of the New Drug Tracing Law

Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA...more

Hatch-Waxman goes to Taiwan

In December 2017, the Taiwan Pharmaceutical Affairs Act has been amended to harmonize generic approval process with prevailing international norms. The amended Act is expected to come into effect in late 2018 or early 2019....more

Alston & Bird Healthcare Week in Review

by Alston & Bird on

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Precision Medicine Advances: Medicare Coverage of Next Generation Sequencing Testing

by Baker Ober Health Law on

Medicare recently released a new national coverage determination (NCD) that addresses certain diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer. NGS technology has made it...more

FDA Releases Five-Year Plans for User Fee Programs

by Goodwin on

Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans...more

What device companies need to know ahead of an advisory panel meeting

by Hogan Lovells on

For companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or approval from the FDA. ...more

Right to Try Legislation: Worthwhile or Window Dressing?

by Pepper Hamilton LLP on

"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more

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