Innovator or Generic, All Roads Lead to the 505(b)(2)
07 Aug 2017
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.
Drug Labeling Specialist on New Pregnancy Labeling Rules
21 Jul 2017
On 30 June, 2015, new pregnancy labeling rules for prescription drugs took effect, marking the demise of pregnancy categories (A, B, C, D, X), which have been in use since 1979.
Experienced Accessible Pharma Professionals and Global Regulatory Services
18 Jul 2017
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...
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.