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

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…

Proposed Generic Drug Labeling “CBE” Rule Turned on its “EAR”?

Changes Being Effected (CBE) As pharmaceutical consultants, PDG has reported extensively on FDA’s Proposed Rule entitled Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. We even gave it our own abbreviated name: the “Generic CBE Rule”. We did so because the rule as originally proposed would allow generic manufacturers to implement safety…

RAPS Reports Generic Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal

PDG™ is a pharmaceutical consultant serving drug sponsors around the world. On July 28, 2014, PDG™ published a chronology of events related to FDA’s proposed rule that would allow generics to use the CBE process to update their labeling with new safety information. Subsequently, RAPS Regulatory Focus (Alexander Gaffney, RAC, October 7, 2014) reported that…

Generic Pharmacovigilance/Safety Surveillance and CBEs

Generic Pharmacovigilance/Safety Surveillance & CBEs

As pharmaceutical consultants, PDG devotes considerable resources to both brand & generic drug safety surveillance and labeling issues.  As such, we have followed with great interest the proposed rule entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.”  For ease of reference, we’re going to begin to refer to it as the…

Transcript for FDA’s Rx to OTC Meeting

As was previously promised, here are the transcripts (1 2) from FDA’s meeting entitled “Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs.” Contact us to find out how our experience can help your company expand your line of prescription and OTC products.

Pharmaceutical Consultant – Marketed Unapproved Drugs

FDA has long held the position that they are subject to take aggressive action against companies that market drugs they consider unapproved. FDA’s most recent notice to industry stated that “any unapproved new drug introduced onto the market after September 19, 2011 will be subject to immediate enforcement action, without prior notice and without regard…

PDG to Attend RAPS Florida Chapter Meeting

Those of you who will be in central Florida this week are welcome to join PDG at an FDA presentation by Leo J Lagrotte, Consumer Safety Officer, Food and Drug Administration (FDA), FLA-DO/TMP-RP entitled “FDA Perspective on Advertising and Promotional Compliance and Social Media” on May 24th, 2012, 5:30–8:30 pm at the Hampton Inn and…