Regulatory

Aug 04, 2017
By BioPharm International Editors
Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.
Aug 01, 2017
BioPharm International
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
Jul 01, 2017
BioPharm International
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Jul 01, 2017
BioPharm International
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
Jul 01, 2017
BioPharm International
The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.
Mar 01, 2017
BioPharm International
Drug type, potential sales, and ownership factor in the race to get drugs to market.
Feb 13, 2017
Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.
Jan 05, 2017
BioPharm International
The number of novel drugs approved in 2016 by FDA’s CDER department was half the number approved the previous year; many of the complete response letters issued in 2016 were a result of preapproval inspection.
Jan 01, 2017
BioPharm International
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
Nov 02, 2016
BioPharm International
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
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