News & Analysis as of

Pharmaceutical Industry The United States Food and Drug Administration

Alston & Bird Healthcare Week in Review

by Alston & Bird on

On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more

Ready to Release a New Pharmaceutical? What to Think About When Selecting Your Drug Name

by Foley & Lardner LLP on

Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and the trademark registration process for candidate drug names. This...more

FDA Approves Zelboraf for Treatment of a Rare Cancer

by Knobbe Martens on

On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more

AGG Food and Drug Newsletter - November 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

FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

by Mintz Levin on

On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

Pfizer Inc. v. Mylan Pharms. Inc.

by Robins Kaplan LLP on

Case Name: Pfizer Inc. v. Mylan Pharms. Inc., No. 15-79-GMS, 2017 U.S. Dist. LEXIS 125634 (D. Del. Aug. 9 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate extended-release tablets);...more

FDA Announces New Draft REMS Guidance

by Goodwin on

Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all...more

FDA Issues Draft Guidance on Breakthrough Devices Program

The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more

Capitol Hill Healthcare Update

by BakerHostetler on

The year-end schedules of the Senate HELP and Finance committees just became more clogged, as the two panels will lead the review of President Trump’s nominee to be Health & Human Services (HHS) secretary. Trump announced...more

Louisiana Adopts Price Reporting Law

by Kelley Drye & Warren LLP on

A new law in Louisiana requires drug manufacturers to report wholesale acquisition cost (WAC) information directly to the state. Louisiana law defines WAC as “the manufacturer’s list price for the pharmaceutical drug or...more

West Virginia Plaintiffs Haunted by Past Excesses

by Reed Smith on

We remember how, shortly after the atrocious decision in Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), rejecting altogether the learned intermediary rule, litigation tourists visiting West Virginia argued that Karl...more

Adverse Event Reports for Food, Supplements and Cosmetics Are Now Publicly Available: What Manufacturers Need to Know

by Pepper Hamilton LLP on

Enhancing transparency has been one of the FDA’s top priorities for nearly a decade. In late 2016, the agency continued to advance this goal by publishing data relating to food, cosmetics and dietary supplements from its...more

FDA Withdraws Draft Guidance For Industry #230

by Reed Smith on

The U.S. Food & Drug Administration (“FDA”) announced in an early morning press release on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, “Compounding Animal Drugs from Bulk Drug Substances.”...more

Big Issues Front and Center at Annual Conference for the American Society for Pharmacy Law

by Faegre Baker Daniels on

In the midst of the opioid epidemic, pharmacists and attorneys from across the country gathered last week for the 28th Annual Conference for the American Society for Pharmacy Law (ASPL). The conference brought together...more

Summary of FDA Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application

On October 13, 2017, the U.S. Food and Drug Administration (FDA) released for comment, by December 12, 2017, draft guidance for industry entitled, Determining Whether to Submit an ANDA or a 505(b)(2) Application. The purpose...more

FDA Issues Long-Awaited Final Guidance on When a Device Modification Requires a New 510(k)

by Hogan Lovells on

Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission of a new 510(k) notice, the U.S. Food and Drug Administration (FDA or the...more

FDA accepts Roche’s sBLA for Avastin

by Goodwin on

This week Roche reported that FDA has accepted their supplemental Biologics License Application (sBLA) for Avastin® (bevacizumab) “in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for...more

Guest Post – Accutane Amici Say: Relax Somewhere Else – Expert Testimony in New Jersey Should Be Held to a Higher Standard

by Reed Smith on

The Accutane litigation in New Jersey has been covered closely by this Blog for its duration. The Blog’s most recent Accutane post evaluated the Appellate Division’s decision to reverse the trial court’s order excluding...more

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

by Hogan Lovells on

Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more

Anticipated Acts of Infringement May Establish Venue for Hatch-Waxman

by McDermott Will & Emery on

Addressing venue in the context of Hatch-Waxman litigation, the US District Court for the District of Delaware held that venue is proper in Delaware if a generic drug company has permanent and continuous presence in Delaware...more

Millennium Pharms., Inc. v. Sandoz Inc.

by Robins Kaplan LLP on

Case Name: Millennium Pharms., Inc. v. Sandoz Inc., Nos. 2015-2066, 2016-1008, -1009, -1010, -1109, -1110, -1283, -1762, 2016 U.S. App. LEXIS 12702 (Fed. Cir. July 17, 2017) (Circuit Judges Newman, Mayer, and O’Malley...more

Medical Device Security: FDA Releases Final Guidance On Interoperable Medical Devices

by Reed Smith on

On September 6, 2017, the FDA issued its final guidance on “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices.” This Guidance is intended to address the tension between...more

FDA Issues Guidance on Drug and Device Classifications

by Arnall Golden Gregory LLP on

On September 26, 2017, the Food and Drug Administration (FDA) announced the availability of a final guidance entitled Classification of Products as Drugs and Devices & Additional Product Classification Issues to clarify FDA’s...more

Bad For Your Health: Lawsuit Advertising Implications And Solutions

by Shook, Hardy & Bacon L.L.P. on

Shook, Hardy & Bacon Partner Cary Silverman has authored a report for the U.S. Chamber Institute for Legal Reform examining the effects of advertising soliciting plaintiffs for lawsuits targeting prescription drugs and...more

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