Search Results for RLD

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FDA Draft Guidance Looks to Help Speed New Generics to Market By Zachary Brennan - Published 13 January 2017

The blitz of new US Food and Drug Administration (FDA) guidance (11 draft and final documents in the last three days) continued on Friday with the release of a draft helping to clarify for generic drug companies how to define and use several terms, and new ways to expedite generic approvals.

Categories: News, FDA, Generic drugs, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: RLD, generic drugs, ANDA, ANDA submission

Generic Drugs Should Look Similar to the Drugs They Reference, FDA Says By Alexander Gaffney, RAC - Published 18 June 2015

The US Food and Drug Administration (FDA) is recommending drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs they reference.

Categories: News, US, CDER, Generic drugs, Prescription drugs, Submission and registration

Tags: Guidance, Final Guidance, RLD, Tablest, Capsules, Size, Shape, Color, Taste

FDA Says it Discovered Problems With Generic Version of ADHD Drug Concerta By Alexander Gaffney, RAC - Published 13 November 2014

A generic attention deficit hyperactive disorder (ADHD) drug manufactured by Mallinckrodt has been found by the US Food and Drug Administration (FDA) to not be sufficiently equivalent to its reference drug, Concerta.

Categories: News, US, CDER, Generic drugs, Postmarket surveillance

Tags: Concerta, Bioequivalence, Therapeutic Equivalence, RLD, ANDA, Orange Book

J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk By Alexander Gaffney, RAC - Published 05 March 2014

Categories: US, FDA

Tags: Sun Pharma, Orange Book, Janssen, J&J, Lipodox, Doxil, RLD, ANDA, Citizen Petition, Latest News, NDA

FDA Now Able to Temporarily Approve Generic Drugs Using Different Label than RLD By Alexander Gaffney, RF News Editor - Published 14 February 2013

Categories: FDA

Tags: Generic Drug, MAPP, 505(j), RLD, ANDA

Senator Plans to Introduce Legislation Reversing Mensing Decision By Alexander Gaffney - Published 29 March 2012

Tags: Pliva, Mensing, Legislation, Court, SCOTUS, Law, Generic, RLD, Latest News, Senate, Bill, Congress

Petitions to Delay Generic Seroquel Denied By Alexander Gaffney - Published 09 March 2012

Categories: FDA, CDER

Tags: Petition, Denial, Antipsychotic, Seroquel XR, Seroquel, AstraZeneca, Denied, Woodcock, RLD, ANDA, Citizen Petition, Latest News

FDA: Tablet Size Matters for Generics By Alexander Gaffney - Published 06 January 2012

Categories: FDA

Tags: Size, Generic, RLD, OGD, ANDA, Tablet, Latest News