Insights

19
May
2020

Should the Pharmaceutical Industry Address Overseas Manufacturing Amid COVID-19?

Recent reports from the United States Food and Drug Administration (FDA) have shown that only 28% of manufacturing for active pharmaceutical ingredients occurs within the nation. While international collaboration on commerce and health are not uncommon, the recent COVID-19 coronavirus pandemic has introduced concerns on whether the country should remain reliant on external supply chains.
Continue Reading ?
12
May
2020

FDA Revises Policy on Antibody Tests: New Focus on Access and Accuracy

On March 16th, the U.S. Food and Drug Administration (FDA) issued a policy regarding antibody tests designed to answer population-level questions about the prevalence of COVID-19. The policy was widely criticized for its permissive guidelines as, in recent weeks, more than 250 companies introduced serology tests to the market. In response, the FDA revised its initial policy on May 4th, imposing newly stringent standards for precision.
Continue Reading ?
05
May
2020

FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment

Since the onset of the COVID-19 pandemic, the Food and Drug Administration (FDA) has worked alongside researchers and innovators with the collective aim of protecting public health. As new treatments are developed, the goal of the administration is to weigh the benefits of these treatments against their potential risks and, if the outcome is favorable, expedite their availability and save as many lives as possible.
Continue Reading ?
28
Apr
2020

COVID-19: The Race to Find the First Vaccine

The coronavirus (COVID-19) pandemic is on everybody’s minds, from pharmaceutical industry employees to the general public. As deaths and infections rise, governments, businesses in the pharmaceutical industry, health groups, and charities are spending billions of dollars in research for a vaccine.
Continue Reading ?
21
Apr
2020

The FDA Response to COVID-19 and the Impacts It’s Having on the Pharmaceutical Industry

The United States Food and Drug Administration (FDA) has been adapting its approach in response to the rapidly-evolving COVID-19 pandemic. The coronavirus and its associated quarantine have impacted not only our daily lives but also how we conduct our business.
Continue Reading ?
14
Apr
2020

The Latest on COVID-19 and the Pharmaceutical Industry

The following is a snapshot of recent news regarding the coronavirus and how the medical community is responding to it. While no currently approved vaccine or treatment is available yet, significant progress and developments have arisen.
Continue Reading ?
07
Apr
2020

Medical Development Disruptions from COVID-19

From non-essential businesses shutting down to distancing ordinances across major cities around the globe, most people have already felt the effects of the novel coronavirus pandemic (COVID-19). Beyond the economic and social impact of COVID-19, the pharmaceutical industry will experience a significant disruption in drug manufacturing, research, and medical development.
Continue Reading ?
24
Mar
2020

COVID-19 Update: The Center for Professional Innovation & Education

During this difficult and often confusing time, our primary concern lies with the health and safety of our customers and employees. We are closely monitoring guidance from the CDC and other health organizations regarding how best to keep everyone safe.
Continue Reading ?
17
Mar
2020

Cybersecurity and Medical Devices: What You Need to Know

The increasing digitization of medical devices has introduced a new threat that the modern pharmaceutical industry fears: the possibility of cybersecurity breaches in our medical equipment. To prevent our essential medical devices from becoming compromised, medical device manufacturers need to ensure they have the proper cybersecurity protocols instilled in their company policies and cultures.
Continue Reading ?
10
Mar
2020

MIT Discovers Powerful New Antibiotic Using Artificial Intelligence

Recently, a deep-learning model allowed researchers at MIT to discover a powerful new antibiotic that could kill several species of bacteria with antibiotic resistance. This machine-learning algorithm was able to clear infections in two different lab mice.
Continue Reading ?
03
Mar
2020

Coronavirus 2020: Everything Pharmaceutical Personnel Should Know

The high-profile coronavirus disease of 2020, also known as SARS-CoV2 and COVID-19, is a major respiratory disease. Now that the number of confirmed worldwide cases reaches 90,000 and the first few deaths from the virus have transpired in the U.S., the people, the U.S. Food and Drug Administration (FDA), and the pharmaceutical industry are making preparations to mitigate the consequences.
Continue Reading ?
25
Feb
2020

How Coronavirus May Change the Way We Approach Pharmaceutical Supply Chains

The well-publicized coronavirus (COVID-19) in China has generated much public anxiety, and even panic, over the spread of the disease. But in addition to the virus itself, we should also think about its effects on commerce and domestic policy in the United States. Early reports have indicated that the virus may lead to a shortage of more than 150 drugs, highlighting a major weakness in the pharmaceutical supply chain.
Continue Reading ?
18
Feb
2020

What the Coronavirus Means for the Pharma Industry

There’s been a lot of commotion over the new coronavirus (2019-nCOV) on the news, and the Food and Drug Administration (FDA) has been quick to respond. However, the government organization has not yet pinpointed any diagnostics, vaccines, or drugs for the treatment and prevention of the new virus. So, the Pharma industry must prepare for the outcome of the Coronavirus.
Continue Reading ?
11
Feb
2020

Industry News: FDA’s Approval of New Peanut Allergy Treatment Drug for Children

The U.S. Food and Drug Administration (FDA) has recently approved Palforzia, a drug that can reduce the effects of allergic reactions to peanuts. Children between the ages of 4 and 17 years can mitigate their symptoms using this drug. Medical services must understand this new development and receive relevant training for its use.
Continue Reading ?
04
Feb
2020

7 Inspiring Life Science Visionaries We’re Celebrating for Black History Month

This Black History Month, the Center for Professional Innovation and Education wants to celebrate the achievements of African-American scientists, researchers, and executives in the biopharmaceutical industry.
Continue Reading ?
28
Jan
2020

The Importance of Keeping Your Medical Writing Training FDA-Compliant

Medical writing involves the creation of scientific documents for a variety of purposes, which can range from submission to medical journals, promotional material on new drugs & medical devices, correspondence with the FDA & EMA to content for healthcare websites.
Continue Reading ?
21
Jan
2020

Understanding the Relationship Between Medical Device Training and Digital Health

Medical device training is becoming more advanced than ever, thanks to the Food and Drug Administration’s (FDA’s) increased focus on digital health.
Continue Reading ?
14
Jan
2020

Process Validation Training: Are Your Processes Meeting Current FDA Guidelines

Process validation is an essential component of any successful company in the pharmaceutical, biotech, medical device, and skin and cosmetics industries. Companies often require additional process validation training to ensure that their internal systems are compliant with the Food and Drug Administration's current guidelines.
Continue Reading ?
07
Jan
2020

cGMP Training: Is Your Company Following cGMP Best Practices?

The quality of manufactured goods is something that the Food and Drug Administration (FDA) takes seriously. CDER established the Quality Initiative and the Office of Pharmaceutical Quality (OPQ) for this reason.

Following Current Good Manufacturing Practices (cGMPs) is one way that pharmaceutical, biotech, and medical device companies can ensure that they are remaining compliant and following industry best practices.
Continue Reading ?