Generic Drug Consulting More Relevant Now Than Ever

Generic Safety Surveillance, Pharmacovigilance and Labeling Consulting Could Be More Relevant Now than Ever

Regulatory Affairs, Research & Development

PDG™ is comprised of pharmaceutical consultants who devote considerable resources to brand and generic post-marketing safety surveillance, pharmacovigilance and labeling supplements. On August 29, 2011, Public Citizen filed a Citizen Petition calling for FDA to authorize ANDA holders to change approved generic labeling using the Changes Being Effected (CBE) and Prior-Approval Supplement (PAS) procedures (among…

Pharmaceutical Consultant’s Update on Smoking Cessation and Generic Drug Safety Surveillance

Labeling / Marketing, Medical Device Consulting News, Pharmaceutical Consulting News, Regulatory Affairs, Regulatory Updates, Safety & Pharmacovigilance

As pharmaceutical consultants with a long history of work in smoking cessation and safety surveillance, PDG® is monitoring two pending proposed rules with great interest. The first is entitled Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations…