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What's new in regulatory science? The FDA will tell you...

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Curious about pharmaceutical developments and resources?

Some of the useful publications are:

American Pharmaceutical Review: An important journal for technology in the pharma industry in North America, including news in: drug delivery, IT, R&D, manufacturing and regulatory affairs.

uCheckOrphan: A useful resource of treatments, clinical trials, R&D news.

EFPIA: The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharma industry in Europe.

Fierce Biotech

Fierce Pharma: https://www.fiercepharma.com/ provide many resorces including information about industry events, trending topics, webinars, virtual events and more.

Fierce Biotech: https://www.fiercebiotech.com/ is the equivalent in the biotech world

GaBI Journal: Generics and Biosimilars Initiative was founded in 2008 by Pro Pharma Communications International and aspire to improve the status of generic and biosimilar medicines. Here you can find information about generic and biosimilar medicines in an open access format.

G.I.T. Laboratory Journal: This journal is for all user currents in the industry - not only laboratory personnel. It provides current information in numerous topics including trending topics and guidelines.

Life Science Leader: This digital version of this business journal for life science executives is designed to provide thought leadership and an in-depth look into industry trends and hot topics that will impact the growth of the pharma and biopharma markets.

Nature Biotechnology: The Nature Research portfolio includes journals, online databases, and services across the life, physical, chemical and applied sciences and clinical medicine. Focusing on the needs of scientists, Nature (founded in 1869) is the leading weekly, international scientific journal. Online, nature.com provides over 6 million visitors per month with access to Nature Research publications and online databases and services.

Nordic Life Science Review: Available in both physical and digital versions, this publication aims to build bridges between readers of industry by providing them with the latest developments, progress and setbacks, in-depth stories and interviews from the Nordic countries.

Pharmaphorum: pharmaphorum is a content and communications company that offer a unique hybrid combination of publishing heritage and journalism with the creativity and expertise of an agency. As a Google-recognised source of “real” news and information, pharmaphorum works with global pharma companies to apply this expertise in publishing, journalism and content-development.

Pharmaceutical Commerce: Written for biopharma commercial executive decision-makers focusing on business processes and the technologies involved in how approved drugs go to market, with the goal of reducing the cost of commercial operations. The online version of this magazine features special web only content as well as all the content available in their print version.

Pharmaceutical Manufacturing: aims to help drug makers understand and improve their processes, and gain manufacturing efficiencies, improving speed to market within the highly regulated Pharma environment.

Pharmaceutical Online: Pharmaceutical Online provides the pharmaceutical manufacturing and packaging industry with exclusive and actionable information to help industry members tackle the challenge of bringing life-saving and life-improving therapies to market.

PharmTech Talk | Pharmaceutical Technology: For biotech professionals looking for dynamic and reliable cutting-edge peer-reviewed content on next-generation process, pharma Tech is best resource for topics including development and manufacturing, formulation, drug delivery, ingredients, regulation, analytics, packaging, supply-chain, and outsourcing. They also provide comprehensive coverage of international regulations and business trends relating to drug development.

Pharma Times: PharmaTimes offers a blend of news stories, interviews, features, case studies, analysis and comment on the critical issues facing the pharma and healthcare sectors. Its wide editorial lens combined with its editorial philosophy to deliver coverage from the perspective of the industry, the payer and the patient allows PharmaTimes to help kickstart conversations that matter most to our audience of decision makers within pharma and the healthcare profession.

PharmaVoice: The primary audience for PharmaVoice is made up of executive and corporate management from pharmaceutical, biotechnology, drug delivery, marketing communications, clinical services, contract research, drug development, and information technology companies, as well as other industry sectors. PharmaVoice has readers from around the world.

SciDoc Publishers: SciDoc Publishers is established with a sole motive to disseminate knowledge among the scientific community. Its publishing model allows them to reach millions of readers and give them access to scientific publications - online, free of charge. Through Open Access, it intends to remove all barriers that traditional publishing models impose. Keeping up to the pace of the 21st century and the vast global research scenario, it ensures accelerated distribution of new developments to the entire scientific community.

Securing Industry: SecuringIndustry.com is an information service that covers the issues surrounding supply chain. It provides practical advice and intelligence to help manufacturers define and pursue their own strategies for tackling crime including counterfeiting, product diversion, adulteration and theft. We cover key developments in the major areas of supply chain like cargo thefts, shipment security and developments in the global regulatory environment.

Stat News: Stat News delivers fast, deep, and tough-minded journalism about life sciences and the fast-moving business of making medicines. It takes you inside academic labs, biotech boardrooms and political backrooms. It casts a critical eye on scientific discoveries, scrutinizes corporate strategies, and chronicles roiling battles for talent, money, and market share. It covers the technologies, personalities, power brokers, and political forces driving massive changes in the life science industry — and a revolution in human healt

Environmental monitoring - best practices in food safety

Establishing a comprehensive environmental monitoring plan can help facilities take a preventative, proactive approach to correcting potential food safety testing issues.

Education and awareness about the measures your facility can take help ensure food safety. In this series, we explore best practices for implementing an effective environmental monitoring program using our Environmental Monitoring Handbook. This resource has been developed with Cornell University and other industry experts. It provides guidance on how those in the food and beverage industry can build and implement a holistic approach based on scientific advice and industry best practices.

In this article, we look at an essential part of this preventative approach, namely testing for indicator organisms and pathogens in food processing environments. These monitoring methods can be used to determine the general hygiene of food processing areas.

Testing for indicator organisms.
Indicator organisms are a group of organisms that reflects the general microbiological condition of a food or the environment. Indicator organism monitoring is conduced to help monitor or validate sanitation and process controls. It provides information about the microbial ecology of food manufacturing areas and assesses post-processing contamination risk The microorganisms tested represent the overall condition of the food environment where the food is being processed.

Aerobic Plate Count (APC), or Total Plate Count (TPC), is one of the most common indicator tests. It provides information about the total population of bacteria present. Simply put, if a manufacturing process is under control, the number of indicator organisms will also be in control. APC counts above a certain threshold suggest that the sanitation of that specific environment was ineffective and/or improperly performed.

Enterobacteriaceae consists of a diverse group of bacteria including coliforms and some pathogens such as Salmonella.

Enterobacteriaceae testing serves the same purpose as coliform testing in that it indicates:

Improper cleaning
Unsanitary conditions
Post-process contamination
Testing for pathogens.
Pathogen tests check for the presence of a specific microbe. Because this microbe can be difficult to find, it is recommended that additional methods be used to validate cleaning and sanitation procedures, such as adenosine triphosphate (ATP) tests and total plate count.

The primary goal for pathogen environmental monitoring programs is to eliminate pathogens and the associated risks for foodborne illnesses and recalls. Foodborne pathogen contamination of finished products typically occurs at a low frequency, which can make finished product testing alone an ineffective strategy for ensuring food safety. Using a pathogen environment monitoring program can help identify contamination sources before they reach a finished food product.

3M pathogen testing.
LEARN MORE.
Environmental monitoring is typically used in facilities that process ready-to-eat (RTE) products or in facilities that handle RTE products. While many different pathogens can cause foodborne illness, only a few are linked to food processing and handling environments. Key pathogens targeted for environmental monitoring programs include Listeria monocytogenes, Salmonella, and Cronobacter spp.

For both indicator organisms and pathogens, a program should be established with sampling procedures and frequency, appropriate test methods, results interpretation, and corrective action procedures. Frequency should be determined and may vary between facility, commodity, and target analyte. Sampling sites should be mapped out with the goal of finding potential issues in the most likely sources of contamination. Quantitative results will be useful in establishing baselines and identifying trends over time.

The FDA holds a workshop about how it conducts postmarketing drug safety surveillance and how adverse event reports are collected, analyzed, and communicated to the public during a free CE webinar on September 28 at 1PM EST.

Register here:

FDA’s Role in Postmarketing Drug Safety Surveillance - September 28, 2 On Tuesday, September 28, 2021, at 1pm (ET), CDER's Office of Communication, Division of Drug Information (DDI) will host a webinar titled: FDA Drug Topics: FDA’s Role in Postmarketing Drug Safety Surveillance. This webinar will provide an overview on how the FDA conducts postmarketing drug safety...

ICYMI: Join FDA on Sep. 21-22 for the public workshop on how outcomes from FDA research conducted under the Generic Drug User Fee Amendments (GDUFA) guide & facilitate generic drug development, regulatory assessment, & approval.

Register at

Advancing Generic Drug Development: Translating Science to Approval Advancing Generic Drug Development: Translating Science to Approval