Search Results for MAPP

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FDA Targets Multiple Review Cycles With New Draft Guidance, MAPP By Zachary Brennan - Published 03 January 2018

Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: ANDA review cycles, generic drug guidance, MAPP

Gottlieb: FDA to Issue new Policies to Streamline Generic Reviews in 2017 By Michael Mezher - Published 18 July 2017

By the end of 2017, the US Food and Drug Administration (FDA) will issue two new documents to improve the review process for generic drugs, according to FDA Commissioner Scott Gottlieb.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: ANDAs, MAPP

Think Tank Seeks Ebola Info from FDA, Calling it a Test Case for Compassionate Use System By Alexander Gaffney, RAC - Published 09 October 2014

A libertarian-leaning think tank is pressuring the US Food and Drug Administration (FDA) to release information regarding the internal approval processes it used to permit two US citizens stricken with Ebola access to Mapp Biopharmaceuticals' ZMapp, an experimental drug.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Ethics

Tags: Ebola, Zmapp, Mapp Biopharmaceutical, Compassionate Use, Expanded Access

New FDA Policy Updates, Clarifies Process of Moving to Electronic Submission Forms By Alexander Gaffney, RF News Editor - Published 22 May 2013

Categories: US, FDA

Tags: MAPP, eCTD

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

New FDA Staff Policy Manual Defines 'Major Amendments' to Generic Drug Submissions By Alexander Gaffney - Published 04 October 2012

Categories: FDA

Tags: Minor Amendment, Major Amendment, Amendments, MAPP, Generic, OGD, ANDA, Latest News, pharmaceutical, drug, review

Revised FDA Manual Provides Statistical Reviewers with Standardized Template By Alexander Gaffney - Published 02 August 2012

Categories: FDA, CDER

Tags: OTS, Template, Statistical Review, Revised, MAPP, Latest News

CDER Provides Guidance to FDA Staff on How to Expedite Review of ANDA Supplements By Alexander Gaffney - Published 01 May 2012

Categories: FDA

Tags: Extraordinary Hardship, Appeal, Expedited Review Request, Supplement, MAPP, ANDAs, OGD, ANDA, Latest News, staff

Owe FDA Money? Don't Bother Submitting an Application, Says CDER By Alexander Gaffney - Published 19 April 2012

Categories: FDA, CDER

Tags: Owed, Arrears, Money, MAPP, debt, User Fees, ANDA, User Fee, application, Latest News, NDA, submission

FDA Seeks to Standardize CDER's Telephone Availability By Alexander Gaffney - Published 29 March 2012

Categories: FDA, CDER

Tags: SOP, Call, Contact, Telephone, Phone, OoM, MAPP, Latest News

FDA Revises MAPP for Regulatory Project Management Site Tours By Alexander Gaffney - Published 27 March 2012

Categories: FDA, CDER

Tags: RPMCC, Site Tours Program, STP, MAPP, Latest News, industry, regulatory