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Six Must-Read Scenarios for FDA Consulting Wednesday, August 31, 2016 by Pharmaceutical Development Group FDA consulting from the perspective of a regulatory strategist: there exists a space between potential Rx-to-OTC drug candidates, medical devices and nonprescription drugs that is ripe for...

Third-Party Reviews for Developments Programmes Thursday, July 14, 2016 by Pharmaceutical Development Group Deciding whether third party review is a favorable cost/benefit proposition for a given 510(k) development programme is not always clear....

Drug Product Label Advice Wednesday, June 22, 2016 by Pharmaceutical Development Group Drug product labelling is the primary communication tool for any drug product....

FDA Expedited Development & Review Programmes Explained Thursday, June 16, 2016 by Pharmaceutical Development Group FDA consultants take note: expedited development and review programmes have now been used by CDER for more than two decades....

Guidance for FDA's Pre-Submission Programme Thursday, June 02, 2016 by Pharmaceutical Development Group Pharmaceutical consulting and generic drug professionals: On February 18, 2014, the final guidance document was released regarding FDA's Pre-Submission programme, Requests for Feedback on...

PDG Releases New White Paper on Adaptive Clinical Trials Monday, January 18, 2016 by Pharmaceutical Development Group The value of adaptive clinical trial consulting and pharmaceutical consulting is highly correlated with up-to-date knowledge of the state of adaptive trial design....

Medical Device Consultants on the 510(k) Program Monday, October 12, 2015 by Pharmaceutical Development Group Medical device consultants tend to take great interest in the dynamic pre-market notification (510(k) regulatory...

Pharmaceutical Consultant Update on Proposed Deeming Rule and Generic CBEs Thursday, September 03, 2015 by Pharmaceutical Development Group As a pharmaceutical consultant engaged in smoking cessation efforts and generic pharmacovigilance for several years, PDG has monitored two proposed rules...

India's Pharmaceutical Industry: a View from a US-Based ANDA/505(b)(2) Pharmaceutical Consultant Wednesday, May 06, 2015 by Pharmaceutical Development Group India's pharmaceutical industry has grown at record levels in recent years but now faces unprecedented challenges as the number of blockbuster drugs scheduled to go off patent begins to...

Orphan Drug Development and the Need for Orphan Drug Consultants Tuesday, May 05, 2015 by Pharmaceutical Development Group As a pharmaceutical consultant, I note that many have speculated the era of the blockbuster drug has ended. 2014 marked the sixth year of a patent cliff in which a majority of US blockbusters...