News & Analysis as of

REMS

Capitol Hill Healthcare Update

by BakerHostetler on

Although House Republicans made progress on bridging ideological differences over how to replace the Affordable Care Act (ACA), GOP leaders say not to expect a vote this week as Congress faces a more immediate deadline: The...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

Capitol Hill Healthcare Update

by BakerHostetler on

House Speaker Paul Ryan’s decision to cancel Friday’s vote on the American Health Care Act triggered post-mortem jockeying among vying GOP factions struggling to come to grips with how the party failed to repeal a law it has...more

FDA 2016 Year in Review

by McDermott Will & Emery on

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

Federal District Court finds brand-name manufacturer’s alleged regulatory delay tactics a valid theory of attempted monopolization

In a recent decision denying the defendant’s motion to dismiss, Judge Mitchell Goldberg of the Eastern District of Pennsylvania allowed the manufacturer of a generic version of Suboxone to proceed upon an interesting theory...more

Protecting Against Big Pharma's Tactics for Delaying Market Entry of Generics

by Tarter Krinsky & Drogin LLP on

Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...more

NYSBA’s REMS and Other Drug Distribution Restrictions Program Provided an Excellent and Informative Discussion

by McGuireWoods LLP on

On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, held a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company...more

REMS and Other Drug Distribution Restrictions – Special NYSBA Program Will Be Held November 10 in NYC

by McGuireWoods LLP on

On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, will put on a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand...more

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

by McDermott Will & Emery on

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

by Foley & Lardner LLP on

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more

Senators Introduce the CREATES Act

by Benesch on

In furtherance of the government’s efforts to bring down healthcare costs, Senators Patrick Leahy (D-VT.), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) have introduced the Creating and Restoring Equal...more

Four Takeaways from the ABA Antitrust Section's 2016 Spring Meeting

by Proskauer Rose LLP on

Antitrust practitioners, enforcers and industry professionals came together in Washington, D.C. for the 64th installment of the ABA Section of Antitrust Law's annual Spring Meeting. The Spring Meeting provides a look at the...more

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA and Antitrust Terrain

by BakerHostetler on

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: Congress and the administration focus on the opioid addiction epidemic... Override of the president’s veto of legislation that would have repealed the Affordable Care Act fails, to no one’s surprise... Senate...more

Blog: FDA Launches New REMS Website

by Cooley LLP on

The U.S. Food and Drug Administration (FDA) launched this week REMS@FDA, a Risk Evaluation and Mitigation Strategy (REMS) database website. The new, user-friendly website contains a table of all currently approved individual...more

REMS and Antitrust: Latest Litigation Lessons

by Robins Kaplan LLP on

Brand name pharmaceutical companies have long stood in the way of generic pharmaceuticals entering the market. To keep generics at bay, brands have used a variety tactics, including ultimately unlawful ones like fraudulently...more

Healthcare Tops the Agenda of U.S. Antitrust Enforcers

by Morgan Lewis on

Agencies promise close scrutiny of hospital mergers, reverse payment settlements, and REMS abuses. During a roundtable discussion featuring federal and state enforcers at the American Bar Association Section of...more

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