Search Results for 505(b)(2)

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The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US By Zachary Brennan - Published 05 September 2017

Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: insulin, Merck, Lilly, Sanofi, Admelog, 505(b)(2), biosimilars

505(b)(2) Approval Pathway: Not Necessarily Shorter Approval Times By Zachary Brennan - Published 09 March 2017

With a goal of avoiding unnecessary duplication of studies performed on a previously approved drug, the 505(b)(2) pathway allows for a more streamlined development and approval process, but for new drug applications (NDAs), the pathway has not led to shorter approval times, according to a recent analysis conducted by the Tufts Center for the Study of Drug Development.

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

Tags: 505(b)(2) pathway, new drug approvals, Tufts, approval times

FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years By Alexander Gaffney, RAC - Published 07 May 2015

Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: eCTD, Electronic Common Technical Document, NDA, BLA, IND, 505(b)(2), DMF, BPF

An Increasing Number of Companies Are Using a Once-Obscure FDA Drug Approval Pathway By Alexander Gaffney, RAC - Published 08 April 2015

Companies are increasingly using a lesser-known regulatory pathway to get new doses, formulations or combinations of drugs approved by the US Food and Drug Administration (FDA), a review by Thompson Reuters has found.

Categories: News, US, CDER, Drugs, Regulatory strategy, Submission and registration

Tags: 505(b)(2)

FDA Cracking Down on Attempts to Delay Entry of Generic Drugs, Data Show By Alexander Gaffney, RAC - Published 18 November 2014

A new report issued by the US Food and Drug Administration (FDA) on the use of petitions meant to delay or prevent the entry of new generic drugs shows that the agency is denying those petitions in record numbers, even as regulators say its authority to dispose of them more easily is lacking.

Categories: News, US, CDER, Generic drugs, Regulatory strategy, Submission and registration

Tags: ANDA, Abbreviated New Drug Application, 505(b)(2) Application, 505(q) Petition, Citizen Petition

Proposed Legislation Overhauls Regulatory Environment for Tamper-resistant Opioids By Alexander Gaffney - Published 24 July 2012

Categories: FDA

Tags: Keating, Definition, 505(b)(2), Legislation, House, Opioids, Latest News, Bill, FD&C Act

Supreme Court Rules Company Can Sue Novo Nordisk For Delaying Generic Medication By Alexander Gaffney - Published 18 April 2012

Tags: Entry, Caraco, Kagan, Novo Nordisk, 505(b)(2), Delay, SCOTUS, Generic, Latest News

Study Calls for Changes to FDA Treatment of Generic Competition By Alexander Gaffney - Published 11 April 2012

Categories: FDA

Tags: 505(b)(2), TriCor, Abbott, Competition, Substitution, Generic, Latest News, pharmaceutical, study, drug