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June 01, 2023
Andrew Newhouse, Pharm.D
director clinical pharmacy
Prescription drug shortages and costs are on the rise — what’s next for the pharmaceutical industry?

There are signs that the supply chain issues we’ve all witnessed over the past several years have started to subside, offering relief to many. That said, the pharmaceutical industry isn’t entirely out of the woods just yet. Supply chain setbacks have…

June 01, 2023 by Andrew Newhouse, Pharm.D, director clinical pharmacy
Blog
December 27, 2022
Mark Buckingham
recall advisor
A decline in European product recalls — and what businesses need to know

According to our latest European product recall index report, the overall number of recall events in Europe fell 8.8% in the third quarter, compared to Q2. The pharmaceutical sector experienced the greatest decline, registering 25.0% fewer events. Th…

December 27, 2022 by Mark Buckingham, recall advisor
Blog
December 20, 2022
Chris Harvey
VP, crisis solution
A record-breaking year for U.S. product recalls — and what businesses can do about it

As supply chains become more disrupted ,regulatory environments more complex, and economic forecasts more uncertain than ever before, companies face increased product liability concerns and exposures. According to our latest U.S. recall index report,…

December 20, 2022 by Chris Harvey, VP, crisis solution
Blog
October 12, 2022
Mark Buckingham
recall advisor
EU still at work on draft proposal to overhaul pharmaceuticals law

Reports indicate that the European Commission’s proposed overhaul of the EU’s general legislation on medicines for human use was rejected by the Regulatory Scrutiny Board, sending it back to the Commission for revision. The Commission was originally…

October 12, 2022 by Mark Buckingham, recall advisor
Blog
September 16, 2022
Chris Harvey
VP, crisis solution
U.S. surpasses milestone of 1 billion product recalls year to date

The total number of U.S. products recalled this year has now topped 1 billion, according to our latest U.S. product Recall Index. More than 1 billion units have been recalled only twice before in history, in 2018 and 2021. However, it took a full yea…

September 16, 2022 by Chris Harvey, VP, crisis solution
Blog
June 01, 2022
Dr. Paul Peak
vice president, clinical pharmacy
Sounding the alarm on ill-advised physician dispensing of topicals

From higher prices at the gas pump to increased costs at the grocery store, we’re all feeling the effects of inflation. Many of the proposed solutions — like fixing supply chain disruptions, increasing computer-chip production, and raising inte…

June 01, 2022 by Dr. Paul Peak, vice president, clinical pharmacy
Blog
April 05, 2022
Amanda Combs
recall consultant
High levels of nitrosamine causing recalls

Over the past few years, several drugmakers have had to recall blood pressure medications due to the presence of excess levels of nitrosamine. It’s happening again. Two major pharmaceutical companies have issued voluntary recalls of several tablet me…

April 05, 2022 by Amanda Combs, recall consultant
Blog
March 11, 2022
Julie Ross, International business development director and Luke Evans, business development manager
European recalls rose in 2021 despite COVID-19 disruptions

As we enter the third calendar year of the COVID-19 pandemic, regulators are adapting to the “new normal.” As reported in our latest edition of the recall index report, product recalls rose by over a quarter (25.5%) across key European industries in …

March 11, 2022 by Julie Ross, International business development director and Luke Evans, business development manager
Blog
March 04, 2022
Chris Harvey
VP, crisis solution
Recall index sees lingering COVID-19 challenges for all key industries in 2022

While regulators and business leaders enter the third calendar year of COVID-19, some new challenges are emerging atop the lingering supply chain and service issues brought on by the pandemic. The Biden administration continues to push for more consu…

March 04, 2022 by Chris Harvey, VP, crisis solution
Blog
February 16, 2022
Mark Buckingham
recall advisor
New EU Clinical Trial Regulation brings positive and negative changes

The European Union Clinical Trial Regulation (CTR) recently came into force and introduced a unified regulatory regime that applies to all EU member states. While the goal of the CTR is to reestablish the EU’s competitiveness in the field of scientif…

February 16, 2022 by Mark Buckingham, recall advisor
Blog
December 13, 2021
Chris Harvey
VP, crisis solution
Regulatory, legal and reputational risks increasing for all businesses in 2022

We are living through a perfect storm of heightened business risks that are impacting every industry — from labor shortages, supply chain issues and inflation to increased regulatory oversight and enforcement. When combined, these risks pose su…

December 13, 2021 by Chris Harvey, VP, crisis solution
Blog
December 08, 2021
Julie Ross
International business development director
Q3 2021 recalls signal a return to pre-pandemic levels

As we emerge from one of the most turbulent and uncertain times in recent history, consumers are eager for a return to normal and economists are predicting a boom as we approach the holiday season. But with so much uncertainty still ahead, it seems t…

December 08, 2021 by Julie Ross, International business development director
Blog
October 16, 2020
Dr. Reema Hammoud
AVP, clinical pharmacy
Psilocybin: From mysticism to healing

Imagine a drug that will take you on a mystical experience where you can ride a dragon or touch the stars, but imagine the same drug can suffocate you under quicksand or imprison you in a sea of volcanic ash. These experiences are not through the mec…

October 16, 2020 by Dr. Reema Hammoud, AVP, clinical pharmacy
Blog
September 18, 2020
Dr. Paul Peak
vice president, clinical pharmacy
Clinical studies: Finding the value and ignoring the noise

Just over 40 years ago, the New England Journal of Medicine published a five-sentence letter to the editor [1] that would be used to ignite one of the worst public health tragedies of our time. Written by a Massachusetts physician and graduate studen…

September 18, 2020 by Dr. Paul Peak, vice president, clinical pharmacy
Blog
October 13, 2015
April Clemens, Business Relationship Manager-PL
Transparency and pharmaceutical drug samples

Kathy Shostek, Vice President Healthcare Risk Management contributed a recent post about the management of drug samples in physician offices. The blog outlined the need for strategies for documentation and management of drug samples for reducing ri…

October 13, 2015 by April Clemens, Business Relationship Manager-PL
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