Tag Archive: FDA

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[…]

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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In February, FDA released a draft guidance with the long title of: “Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)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[…]

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Bart’s Corner: AE Reporting FDA Draft Guidance

In February, FDA released a draft guidance entitled “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.”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 This draft guidance notes that and then notes that such facilities must submit[…]

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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[…]

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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[…]

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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[…]

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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[…]

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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[…]

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Pharma’s Next Step: Tapping into Social Media to Support Critical Initiatives

Increase in social media adoption by both patients and physicians is beginning to catch the attention of market leaders within the pharmaceutical industry. While there is undoubtedly greater interest in utilizing social media capabilities, many pharmaceutical manufacturers are struggling to understand how social media activities support their core business goals.[…]

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Bart’s Corner: The Sentinel and Mini-Sentinel Initiatives

In 2008 in response to criticism and some safety issues and product withdrawals, FDA took a look at itself – with some outside help such as the FDA Amendments Act (FDAAA). This new law mandated the FDA to establish an active surveillance system for monitoring drugs using electronic data from[…]

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