Pharmaceutical Consulting and Generic Drug Professionals
16 May 2016
On November 13, 2013, FDA proposed a new rule known as the 'Supplemental Applications Proposing Labelling Changes for Approved Drugs and Biological Products'.
Clinical Trial Consulting, Pharmaceutical Consulting and Adaptive Clinical Trial Design
15 Jan 2016
Clinical trial consulting and pharmaceutical consulting professionals will benefit by becoming current on adaptive trial design.
Medical Device Consultant on 510(k) Submissions
08 Oct 2015
As a medical device consultant, PDG® takes great interest in the ever-changing landscape of the premarket notification (510(k) review and clearance process.
Drug Labeling Specialist on New Pregnancy Labeling Rules
01 Jul 2015
On June 30, 2015, the new pregnancy labeling rules for prescription drug labeling took effect, marking the demise of pregnancy categories (A, B, C, D, X), in use since 1979.
Innovator or Generic, All Roads Lead to the 505(b)(2)
30 Apr 2015
Faced with decreasing R&D output, billions of dollars in patent expirations and increasing generic competition, innovators are forced to re-evaluate traditional business models.
Experienced Accessible Pharma Professionals and Global Regulatory Services
30 Apr 2015
PDG has experienced and accessible full-time professional staff and expert consultants including a multidisciplinary team of pharmacologists, toxicologists, clinicians, epidemiologists, statisticians, analytical scientists, regulatory professionals a...