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The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. So, what can we learn from the importance of Quality Assurance in generic drugs?
For context, we speak to the authors of The Truth Pill: The Myth of DrugRegulation in India. The World Health Organization has issued an alert about the deaths in the West African nation of Gambia. Image credit: Milan Berckmans/AFP via Getty Images)
Some of the TV spots for drugs are horrible, and some products should even be on TV because of terrible fair balance. ” Then there is a spot for a drug for cancer patients that has a forgettable name. The other issue few people talk about is that the level of talent within the DTC marketing pool has been contaminated.
The US Food and Drug Administration (FDA) posted the company’s recall announcement , which includes a complete list of products affected by the recall. . So why is metal contamination such a common reason for launching voluntary recalls? The Mars recall impacted 13 product stock keeping units (SKUs) ranging from 3.5-ounce
Approval of the Month: Repurposed Transplant Drug Approved Based Only on Real-World Evidence. The House Committee on Energy and Commerce recently sent a letter to the FDA (specifically Acting Commissioner Janet Woodcock) asking for information regarding the re-initiation of inspections at FDA-regulated sites.
SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminateddrugs to pharmacies, and marketing drugs for unapproved uses. Johnson & Johnson has paid $2.7 billion in penalties. Ethical leadership!
Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems. Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S.
The presence of lead in food remains a critical concern for the US Food and Drug Administration (FDA). Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. The FDA employs a rigorous process to determine if lead levels in food constitute a health risk.
In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses.
coli outbreak between 1992 and 1993 that claimed the lives of four children who had eaten contaminated burgers from the fast-food chain Jack in the Box. This heart-wrenching event prompted an increased focus on fast-food safety regulations. But the documentary argued that more regulatory work is still needed. It becomes a commodity.”
Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. Today, the U.S. Families rely on stores like Family Dollar for products such as food and medicine.
New regulations are often reflective of the supply chain, food safety and consumer trends. Here are some of the top food industry regulations food and beverage companies should watch out for in 2022. Changes to the US Food and Drug Administration’s Definition of “Healthy”. Regulating Heavy Metals in Baby Food.
Pesticides continue to linger on our food, even on crops where their use has been banned, pointing to systemic issues in food safety regulations. The EWG also provides a “Clean Fifteen” list , highlighting produce with the least pesticide contamination. Reducing and Avoiding Pesticides It’s not all doom and gloom.
The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. an Illinois-based processor of sprouts and soy products.
The report sheds new light on executives’ worries about deficiencies in the company’s quality control systems at its troubled Baltimore plant; no contaminated doses were ever released to the public.
To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.
The US Food and Drug Administration (FDA) recently announced the launch of a pilot program to assess whether services provided by third-party food safety auditors align with the requirements set out by the Food Safety Modernization Act (FSMA). Related: Is the FDA Doing Enough to Regulate Added Chemicals in Foods? Amid Salmonella and E.
Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. By Sophia R.
Assuring end-patient safety through holistic contamination control. With advances in rapid microbiological methods, revised industry regulation, enhanced knowledge of innovative therapies, and novel testing methods, this industry is ever expanding. Sponsored by: Associates of Cape Cod, Bioscience International and Ecolab.
In another study evaluating the microbial load of a plant-based meats, the researchers concluded the products they studied were susceptible to post-processing contamination. FDA Regulation. The storage and handling of these products should mimic that of raw meats,” the authors wrote. Dietary and nutritional factors.
While the voluntary recall has not been posted on the US Food and Drug Administration’s (FDA) website , reports indicate that the affected products were distributed in Connecticut, Maine, Maryland, New Jersey, New York, North Carolina, Pennsylvania and Virginia. Here’s everything you need to know about the Coca-Cola recall.
These tiny particles, primarily from environmental contamination, can infiltrate the food supply. Microplastics and nanoplastics primarily contaminate food through environmental exposure where crops and livestock are raised. Macroplastics and microplastics are growing concerns within the food industry.
They are caused by bacteria, viruses, parasites or chemical substances entering the body through contaminated food or water. An estimated 420,000 people in the world die every year after eating contaminated food, with children under five years old carrying 40 percent of the foodborne disease burden.
In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). Xtalks spoke to Betsy Craig, CEO and founder of MenuTrinfo, to find out how the company certifies products and where government regulations fall short. We go to the facility.
for an Improved, Efficient and Contaminant-Free Cleanroom. Key Reasons to attend: Learn how to maximise the latest cleanroom technologies to modernise your contamination control strategy. Increase your cleanroom availability & accessibility through streamlined approaches to contamination control. Advances in Pharma 4.0
Last week, the US Food and Drug Administration (FDA) issued its final rule on Requirements for Additional Traceability Records for Certain Foods , which includes food traceability protocols for a variety of food products susceptible to contamination. Related: Here’s How the FDA is Making it Easier to Trace Foods.
Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? The US Food and Drug Administration (FDA) estimates that nearly 48 million people are sickened by food contaminated with harmful germs each year, with produce being the culprit in many cases.
Data indicates that the global nanopharmaceutical drugs market size reached USD 53.85 Regulations and guidelines for nanopharmaceuticals are still relatively in their infancy, including for cleaning processes and the prevention of cross-contamination. Billion in 2021 and is expected to reach USD 102.4 Billion in 2030.
The presence of lead in food remains a critical concern for the US Food and Drug Administration (FDA). Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods.
Food and Drug Administration (FDA) announced today that Bravo Packing, Inc., an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Related Information.
As a staple spice in many kitchens, the discovery of elevated lead levels in cinnamon products has prompted a closer look at food safety practices and regulations. Why Cinnamon is Prone to Higher Lead Levels Cinnamon can become contaminated with lead through various pathways. One primary source is environmental contamination.
These therapies have emerged as viable alternatives to traditional treatment options, including small molecule drugs. Steps Involved in Cell Therapy Manufacturing Process Manufacturing biologics and cell therapies is considerably complex when compared to small molecule drugs.
While there are multiple avenues through which raw milk can legally be sold — from retail spaces to direct farm-to-consumer transactions or through herd share schemes — each of these distribution methods has its own set of regulations, primarily to safeguard the buyer. percent of American adults reported consuming raw milk in the past year.
The recalls affect cookies, broccoli-cheddar soup and falafel, raising concerns over possible contamination with foreign objects like insects or rocks. ” The Trader Joe’s recall appears to be a voluntary move , a common practice amongst companies facing contaminated food products. .”
Furthermore, the report listed an additional 35 potential risks, identified by EREN members representing a range of global food safety organizations including the World Health Organization (WHO) and the US Food and Drug Administration (FDA).
The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.
Food and Drug Administration says. During the COVID-19 pandemic, there has been a large increase in hand sanitizers from Mexico that are labeled to contain ethanol (also known as ethyl alcohol) but have tested positive for methanol contamination, according to the agency. consumers in mind.” ” More Information.
Last month, an American activist group called the Environmental Working Group (EWG) announced its annual Dirty Dozen List , a list of the most pesticide-contaminated fresh produce based on the latest tests by the US Department of Agriculture (USDA) and US Food and Drug Administration (FDA).
While the US Food and Drug Administration (FDA) would normally issue a recall, no recall was issued because the products are no longer available for purchase. In April, the FSIS announced that the New Jersey-based company Lakeside Refrigerated Services was recalling over 120,000 pounds of ground beef products that may be contaminated with E.
“The COVID-19 pandemic has accelerated the necessity for the FDA to assist make sure that foods ordered online and delivered on to consumers are safe to eat and not in danger of contamination. Food and Drug Administration will meet with members of the food industry, regulatory counterparts in the least levels of state , consumers, et al.
The team talks about the lack of oversight from federal authorities like the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) and wonder whether consumers are partially to blame for high demand. The film unpacks a variety of food safety issues, starting with the notorious E.
Called the “BioNTainer,” the container solution will consist of the active drug substance and one formulation module, each called a BioNTainer. He said this is because “we know that mRNA is a new drug class, which is suitable for different types of vaccines.”.
It also found detectible levels of phthalates in food handling gloves, which researchers said could be a source of contamination. Despite the potential health risks of consuming high levels of phthalates, the US Food and Drug Administration (FDA) has no legal thresholds limiting the chemical in foods.
After voters approve the measures, the state legislatures usually will need to set up regulations in each state. Arizona’s law will allow adults aged 21 and older to possess, consume or transfer up to 1 ounce of cannabis and create a regulatory system for the drug’s cultivation and sale. Drug and Food Administration.
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