Tag Archive: FDA

Compliance, Quality & Cost: Outsourcing Clinical Trial Support

Compliance, Quality & Cost: Why Outsourcing Clinical Trial Support Makes Sense for Start-Up and Mid-Sized Drug Manufacturers Clinical development of a drug or device from discovery through post-marketing approval requires a vast amount of time and resources. During the clinical trial phase, requirements and regulations imposed by governing regulatory bodies[…]

Read More

FDA’s May 2015 Draft Guidance for Investigator Initiated Trials / Studies

Industry expert Bart Cobert reviews the FDA's latest draft guidance for Investigator Intiated Trials & Studies

Read More

Bart’s Corner: FDA’s New REMS Guidance

In April, FDA released a final guidance on Risk Evaluation and Mitigation Strategies (REMS): Modifications & Revisions. The title is a bit of a misnomer. This is not really a modification or revision of the big issues involved with REMS creation and implementation, but rather gives guidance to companies that[…]

Read More
Drug Safety and Tissue-Based

Bart’s Corner: Drug Safety & Tissue-Based Products FDA Guidance

In February, FDA released a draft guidance with the long title of: “Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271.” This is a guidance that FDA[…]

Read More

Bart’s Corner: AE Reporting FDA Draft Guidance

In February, FDA released a draft guidance entitled “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Section 503B refers primarily to compounding pharmacies and Good Manufacturing Practices (GMP). This draft guidance notes that and then notes that such facilities must submit[…]

Read More

Bart’s Corner: The ISMP Report on Drug Safety Reporting – Part 2

Continued from Part 1. We continue with the analysis of the Institute of Safe Medication Practices’ recent report on FDA and FAERs of late January 2015 entitled “A Critique of Key Drug Safety Reporting System.” Gaps in FDA FAERS Coverage The report also comments on some FAERs issues. AEs in[…]

Read More
ISMP Report on Drug Safety Reporting_Part 1_

Bart’s Corner: The ISMP Report on Drug Safety Reporting – Part 1

The Institute for Safe Medication Practices (ISMP) issued a report in their QuarterWatch bulletin in late January 2015 entitled “A Critique of a Key Drug Safety Reporting System”. The report was picked up fairly widely in the media. See the NY Times. This is a very important report and it[…]

Read More
Explaining Drug Safety & PV

Explaining Drug Safety & PV to Senior Management… and Your Mom!

In the course of many years in pharma heading drug safety groups and now consulting, training and doing outreach to the public, I continue to be amazed and humbled by the lack of knowledge by the public about drug safety and what those little pills you pop in your mouth[…]

Read More
Bart's Corner: REMS Update

Bart’s Corner: REMS Update

In September 2014 FDA issued a paper on Standardizing & Evaluating Risk Evaluation and Mitigation Strategy (REMS). A REMS is put in place for those products to ensure that benefits outweigh the risks. REMS may require additional measures above and beyond the usual post-marketing safety surveillance by the sponsor. This[…]

Read More
PV / Drug Safety Crises

Bart’s Corner: PV Crises

This is a follow up to the previous posting on PV Stress Tests. During every PV person’s career, a “PV crisis” will arise. PV “crises” can occur in clinical trials or during marketing and may be of varying degree and type; so let’s define them first. Although the following are[…]

Read More

The Experience Matters.

As an industry leader in business process outsourcing, C3i Solutions delivers global, multi-channel engagement solutions. The Experience Matters. Let us show you why.

Contact Us