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Pharmaceutical Consulting and Generic Drug Professionals Monday, May 16, 2016 On November 13, 2013, FDA proposed a new rule known as the 'Supplemental Applications Proposing Labelling Changes for Approved Drugs and Biological Products'....

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Clinical Trial Consulting, Pharmaceutical Consulting and Adaptive Clinical Trial Design Friday, January 15, 2016 Clinical trial consulting and pharmaceutical consulting professionals will benefit by becoming current on adaptive trial design....

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Medical Device Consultant on 510(k) Submissions Thursday, October 08, 2015 As a medical device consultant, PDG® takes great interest in the ever-changing landscape of the premarket notification (510(k) review and clearance...

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Drug Labeling Specialist on New Pregnancy Labeling Rules Wednesday, July 01, 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....

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Innovator or Generic, All Roads Lead to the 505(b)(2) Thursday, April 30, 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....

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Experienced Accessible Pharma Professionals and Global Regulatory Services Thursday, April 30, 2015 PDG has experienced and accessible full-time professional staff and expert consultants including a multidisciplinary team of pharmacologists, toxicologists, clinicians,...