What is an FDA U.S. Agent?

What is an FDA U.S. Agent?

February 2, 2018: PDG® is a global pharmaceutical consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and in FDA regulatory affairs. As such, PDG is an integral part of client decision-making processes with regard to the designation of FDA U.S. Agents and Official Contacts. In addition,…

An Introduction to Clinical Trials and Resources for Continued and Intermediate Learning

In January 2018 this introduction to clinical trials was prepared by the pharmaceutical consultants at PDG who routinely design and write clinical trial protocols. This paper represents a collection of quotes and resources ranging from basic primers to more advanced concepts. This is provided for drug and medical device professionals who may not serve in…

EMA Drug Post-Marketing Safety Surveillance Changes, US Impact and Compliance Assistance

On November 22, 2017, EMA launches a “new and improved” version of EudraVigilance (analogous to FDA Medwatch program). The result will be a total transition in the way that Individual case safety reports (ICSRs) are tracked and reported throughout Europe. ICSRs will be reported to the EudraVigilance database in the E2B(R3) format, replacing the E2B(R2)…

Taking a drug holiday

Drug Holidays – Temporary Suspension of Therapy; Drug Labeling Consultant’s Perspective

Drug holidays are not often described in the U.S. professional labeling of prescription drug products. However, they are routinely employed across various classes of drugs as well as a variety of patient populations. As the name implies, a drug holiday is the temporary suspension of active therapy[1], and is usually enacted to avoid adverse events…

When to Change Prescription Drug Labeling

When to Change Drug Labeling?

You don’t have to be a drug labeling consultant to realize that a case series of serious events in the literature, FDA safety alert, FDA labeling change notification letter, or other new safety information should prompt a review of drug product labeling (aka package insert). That is not what this paper is about. This paper…

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…

New Pregnancy Drug Labeling Rules Take Effect (white paper)

New pregnancy labeling rules for prescription drugs took effect, June 30, 2015, marking the demise of the pregnancy categories (A, B, C, D, X), in use since 1979. The new rule ushers in what is expected to be an unprecedented era of inclusion regarding descriptive risk and benefit information. According to FDA, “a narrative structure…

Investigational New Drug Application (IND)/Special Protocol Assessment (SPA)

FDA Delays Publication of Generic Drug CBE Rule Until Fall 2015

In a move that was not entirely unexpected, FDA delayed publication of a rule proposed last year that would allow generic drug sponsors to update safety warnings using the changes being effected (CBE) process. While the comment period had earlier been extended, there was no corresponding extension in the scheduled publication date of December 2014.…

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…