Search Results for Orphan Drug Act

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FDA Analyst Counters Critiques of Orphan Drug Act By Michael Mezher - Published 18 October 2017

While recent reports have claimed that drugmakers are manipulating the incentives provided by the Orphan Drug Act, Mike Lanthier, an operations research analyst at the US Food and Drug Administration (FDA), says that in most cases, the act is working as intended.

Categories: News, FDA, Biologics and biotechnology, Drugs, Orphan products

Tags: Orphan Drugs, Orphan Drug Act

Sen. Grassley Opens Inquiry Into Orphan Drug Act By Zachary Brennan - Published 10 February 2017

Sen. Charles Grassley (R-IA) on Friday confirmed to Focus that he is gathering more information and discussing with his staff and interested parties a possible inquiry into the Orphan Drug Act’s abuses leading to high drug prices.

Categories: News, US, FDA, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Orphan Drug Act, Grassley, orphan drugs

Johns Hopkins Researchers Call for Orphan Drug Reform By Michael Mezher - Published 20 November 2015

A team of researchers at Johns Hopkins are calling for reforms to the Orphan Drug Act, saying that loopholes have allowed drug companies to skirt the act's intent by taking advantage of its incentives for non-orphan conditions.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: Orphan Drug Act, Johns Hopkins

Studies Raise New Concerns Over FDA's Expedited Approval Designations, Supplemental Indications By Zachary Brennan - Published 24 September 2015

An increasing number of newly-approved drugs by the US Food and Drug Administration (FDA) have been associated with expedited development or review programs, though many of these approved drugs are not first in class and potentially less innovative, according to two new studies published in the British Medical Journal (BMJ).

Categories: News, US, FDA, Drugs, Due Diligence, Government affairs, Orphan products, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: orphan drugs, expedited review, fast-track approval, FDA, Orphan Drug Act, rare disease

FDA Exercising 'Extraordinary' Flexibility on Drugs for Rare Diseases, New Study Finds By Alexander Gaffney, RAC - Published 04 May 2015

The US Food and Drug Administration (FDA) is a reasonable regulator. That's the conclusion of a new analysis looking at the measures taken by FDA to review and approve new drugs intended for use in rare diseases affecting small populations of patients.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Orphan products

Tags: Orphan Drug Act, Rare Disease, Orphan Drugs

Orphan Drugs Around the World: The Regulations and Requirements You Need to Know By Meredith Brown-Tuttle, RAC - Published 17 September 2014

"Orphan drugs" are product intended for use in the treatment of a "rare" disease—those diseases that occur infrequently or rarely in the general population of a specific location. 

Categories: Features, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, EC, EMA, FDA, PMDA, TGA, Biologics and biotechnology, Drugs

Tags: Orphan Drugs, Orphan Disease, Orphan Drug Act, Ultra-Orphan Diseases, Orphan Drug Regulations

New FDA Guidance Tries to Define When Antibody Products are 'The Same' By Alexander Gaffney, RAC - Published 23 April 2014

Categories: US, FDA

Tags: Market Exclusivity, Sameness, Same, ODA, Biosimilarity, Orphan Drug Act, Latest News, BPCI, biosimilar, guidance

New FDA Guidance Tries to Define When Antibody Products are 'The Same' By Alexander Gaffney, RAC - Published 23 April 2014

Categories: US, FDA

Tags: ODA, Orphan Drug Act, BPCI, guidance

FDA Guidance: How to Improve Your Meetings With the Office of Orphan Product Development By Alexander Gaffney, RAC - Published 10 April 2014

Categories: Meetings, US, FDA

Tags: Orphan Drug Designation, Orphan Drug Act, Meeting, Latest News, OOPD, Orphan Drugs, Rare Diseases, draft guidance

As US Population Grows, Rare Diseases Become Even Rarer By Alexander Gaffney, RAC - Published 15 January 2014

Categories: US

Tags: Orphan Drug Act, rare disease, Orphan Diseases, Latest News, Orphan Drugs

FDA Announces $14 Million in Grants for Trials in Support of Rare Disease Therapies By Alexander Gaffney, RF News Editor - Published 21 October 2013

Categories: US, FDA

Tags: Neglected Diseases, Grant, Orphan Drug Act, Latest News, Orphan Drugs, Rare Diseases

With Incentives Lacking for Some Orphan Diseases, FDA Considers New Guidance By Alexander Gaffney, RF News Editor - Published 11 June 2013

Categories: US, FDA

Tags: Orphan Drug Act

FDA Finalizes Changes to Orphan Drug Regulation, With Emphasis on Clarifying Existing Policies By Alexander Gaffney, RF News Editor - Published 11 June 2013

Categories: US, FDA

Tags: Orphan Drug Act

Is FDA Leaving Orphans Out in the Cold? By Alan Minsk - Published 22 February 2013

In the last 12 months, the US Food and Drug Administration (FDA) has taken certain actions that, on their face, seem to be potentially limiting the benefits of orphan drug exclusivity (ODE). FDA's actions are worth a review because they demonstrate that the once-sacrosanct ODE is not invincible.

Tags: Orphan Drug Act, ODE

30 Years Later, FDA Looks Back on Passage of Orphan Drug Act By Alexander Gaffney, RF News Editor - Published 04 January 2013

Tags: Orphan Drug Act, Milestone

In Landmark Reversal of Policy, Health Canada Announces Launch of Orphan Drug Policy By Alexander Gaffney - Published 04 October 2012

Categories: Health Canada

Tags: Orphanet, Orphan Drug Act, Latest News, Orphan Drugs, Rare Diseases

Group Advocates Treating Superbugs Like Rare Diseases By Alexander Gaffney - Published 08 March 2012

Categories: FDA

Tags: antibiotics, bacteria, Super bugs, IDSA, Orphan Drug Act, Superbugs, Orphan Diseases, Latest News, Rare Diseases