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The United States Food and Drug Administration Pharmaceutical Industry

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 -

Due Diligence: Calculating the Regulatory Review Period for Patent Term Extension

by Pepper Hamilton LLP on

This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more

FDA Advisory Committee Recommends Approval of Pfizer’s EPOGEN®/PROCRIT® Biosimilar

by Goodwin on

As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer,...more

BPCIA Litigation Roundup (Spring 2017)

by Goodwin on

Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

The Life Sciences Report - Summer 2017

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

Public Comment Period Closes for FDA’s Draft Interchangeability Guidance

by Goodwin on

On May 19, 2017, the period for submitting public comments on the FDA draft guidance on biosimilar interchangeability closed (for a discussion of the FDA draft guidance click here). The draft guidance was published on...more

Picking Up the Post-Preemption Pieces

by Reed Smith on

Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case. Applying a ruling on in limines from one case to another can be a dicey proposition...more

Materials Available for May 25, 2017 ODAC Meeting Regarding Hospira’s Epoetin Alfa Biosimilar Application

by Goodwin on

As we previously reported, the FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit®...more

Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other...more

AAM/Biosimilars Council Comments on FDA Draft Guidance on Interchangeability

by Goodwin on

The Association for Accessible Medicines (AAM) and the Biosimilars Council, a division of AAM, released comments today on FDA’s Draft Guidance on Considerations in Demonstrating Interchangeability With a Reference Product...more

Update on Biosimilar Approvals and Pending Applications in Europe and the U.S.

Approvals of biosimilar products in Europe continue to outpace those in the United States. 28 biosimilars are currently approved in Europe and five in the U.S. In 2017, the European Medical Agency has approved six...more

AGG Food and Drug Newsletter - May 2017

by Arnall Golden Gregory LLP on

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

Capitol Hill Healthcare Update

by BakerHostetler on

Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after...more

In re copaxone consolidated cases

by Robins Kaplan LLP on

Case Name: In re copaxone consolidated cases, No. 14-1171-GMS (consolidated) 2017 U.S. Dist. LEXIS 12168 (D. Del. Jan. 30, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Copaxone® (prefilled syringes of...more

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

by Pepper Hamilton LLP on

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

by Hogan Lovells on

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2. Please see full...more

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

by Arnall Golden Gregory LLP on

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

Scott Gottlieb’s Stance on Biosimilars

by Goodwin on

On May 11, 2017, Scott Gottlieb was sworn in as the 23rd Commissioner of the U.S. Food & Drug Administration. Before his confirmation, Gottlieb was vocal about his disapproval of the FDA’s “well-established” attitude: an...more

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

by Arnall Golden Gregory LLP on

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

Par Pharm., Inc. v. Luitpold Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Par Pharm., Inc. v. Luitpold Pharms., Inc., No. 16-2290 (WHW)(CLW), 2017 U.S. Dist. LEXIS 15050 (D.N.J. Feb. 1, 2017) (Walls, J.). Drug Product and Patent(s)-in-Suit: Adrenalin® (epinephrine); U.S. Patents...more

Xarelto Litigation – Bellwether Update

Searcy Denney Mass Tort Unit attorneys Brenda Fulmer and Cal Warriner have filed three more lawsuits on behalf of Florida and North Carolina residents who suffered bleeding in their brains and GI tracts following use of...more

The Federal Circuit’s First Application of the AIA’s On-Sale Bar: Implications for Bio/Pharma

When a small pharmaceutical company discovers a new medicine, it’s not uncommon for the company – which may not itself have the resources or infrastructure to get that medicine to patients – to seek a distribution partner...more

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

by Jones Day on

On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

21st Century Cures: What's In the Box?

by Mark Mansour on

One of FDA’s most important tasks in the coming months will be the implementation of the 1,000 page long 21st Century Cures bill, enacted last year. We have assembled a quick, bullet-pointed summary of some of the major...more

100 Days Plus Under Trump: What They Mean for Biologics

President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more

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