Regulatory

Aug 30, 2017
By BioPharm International Editors
FDA issued a Refusal to File letter to Acorda Therapeutics, citing insufficiently complete information in the company’s new drug application for its investigational Parkinson’s disease drug.
Aug 28, 2017
By BioPharm International Editors
FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.
Aug 18, 2017
By BioPharm International Editors
The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.
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 29, 2017
The mAb is the first approved treatment that targets the progressive form of the disease.
Mar 01, 2017
BioPharm International
Drug type, potential sales, and ownership factor in the race to get drugs to market.
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