FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022.

Manufacturing 59

Manufacturing Production Drugs FDA Compliance 59

Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

Manufacturing 40

Manufacturing Hormones Contamination Containment 40

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

Clinical Research 52

Clinical Research Compliance Research Clinical Trials 52

XTalks

JUNE 7, 2022

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.

Contamination 98

Contamination Bacteria Regulation Development 98

XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Jardiance brought in $2.06

Sales 52

Sales Insulin FDA Approval Drugs 52

Pharmaceutical Technology

OCTOBER 26, 2022

Data indicates that the global nanopharmaceutical drugs market size reached USD 53.85 According to GlobalData’s Nanopharmaceuticals Thematic Research report, the vast majority of marketed and pipeline nanopharmaceuticals are being used to treat a wide range of cancer indications, highlighting the ongoing unmet needs in this area.

Manufacturing 130

Manufacturing Drug Delivery Systems Contamination Drug Delivery 130

XTalks

DECEMBER 1, 2021

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. Where the gadget will fit into the $19.5

Contamination 98

Contamination Packaging Packaging Regulation 98

XTalks

AUGUST 3, 2021

The National Council of Negro Women (NCNW) filed a lawsuit last week asking courts to make Johnson & Johnson create equally targeted “corrective marketing,” and/or fund outreach efforts warning Black women and their families about the risk of ovarian cancer associated with its product.

Containment 98

Containment Production Contamination Marketing 98

Pharmaceutical Technology

DECEMBER 20, 2022

Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety. With operator intervention being a primary source of contamination, finding ways to reduce human contact has been an ongoing challenge and goal in aseptic filling.

Regulation 130

Regulation Contamination Manufacturing Production 130

XTalks

OCTOBER 16, 2023

Similarly, in Wyoming, the Department of Health confirmed that five people — one adult and four children — fell ill after ingesting raw milk purchased from Slow Food in the Tetons online market. Two children from this group were hospitalized. Coli bacteria. percent of American adults reported consuming raw milk in the past year.

Bacteria 104

Bacteria Sales Contamination Regulation 104

XTalks

JANUARY 25, 2023

Abbott, the maker of Similac and other popular baby formula brands, was forced to recall several powdered infant formulas and stop production after the US Food and Drug Administration (FDA) found evidence of unsanitary conditions. Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner?

Bacteria 52

Bacteria Contamination Production Regulation 52

The Pharma Data

MAY 3, 2021

Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . . Regulatory intelligence activities are complicated by the push for stronger product sales in emerging markets.

Development 52

Development Contamination In-Vitro Production 52

Delveinsight

SEPTEMBER 8, 2021

There are several challenges faced by any company entering or persisting in the market, few of which are managerial, statistical, financial, and analytical decisions to be made by a client organization for which they would require people possessing more knowledge in the specified field that can serve as an advantage.

Marketing 52

Marketing Production Sales Life Science 52

pharmaphorum

JUNE 28, 2022

Gilead Sciences has refiled for FDA approval of its HIV capsid inhibitor lenacapavir – which only needs to be dosed every six months – after the drug was rejected by the regulator in February. The post Gilead tries again with twice-yearly HIV drug lenacapavir appeared first on.

Drugs 105

Drugs Contamination Sales Marketing 105

Pharmacy Checkers

DECEMBER 12, 2019

wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. is not the gold standard in drug safety, it would fatally weaken anti-importation arguments. If the U.S.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

XTalks

MAY 13, 2022

Container closure systems are highly regulated by health agencies. With a network including North America, Europe and Asia, Curia aims to improve patient outcomes and quality of life by offering a complete suite of solutions across its three divisions: Discovery, Development and Analytical (DDA), Drug Product and API Manufacturing.

Packaging 98

Packaging Packaging Containment Production 98

pharmaphorum

NOVEMBER 24, 2022

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. And even once the facility is fit for purpose, specialised staff are required to maintain compliance with strict regulations. Meeting strict standards.

Manufacturing 98

Manufacturing Pharma Packaging Packaging Packaging 98

XTalks

MAY 30, 2023

The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments.

Drug Delivery 98

Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

Pharmacy Checkers

NOVEMBER 21, 2019

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.

Generic Drugs 68

Generic Drugs Manufacturing Regulation Drugs 68

pharmaphorum

AUGUST 22, 2022

The European Commission has become the first regulator worldwide to approved a therapy from Gilead Sciences for people with multidrug-resistant (MDR) HIV infection that only needs to be taken twice a year, after the FDA rejected it earlier this year. It is dosed as an injection given every six months after an initial oral dose-loading course.

Contamination 98

Contamination Marketing Regulation Drugs 98

Drug Discovery World

AUGUST 10, 2022

By Mark White, Associate Director of Biopharma Product Marketing at Bio-Rad and Marwan Alsarraj, Biopharma Segment Manager, Digital Biology Group. Exactly three decades later, the first CAR T cell therapy hit the market. For example, it is challenging to regulate transgene copy numbers in each T cell, posing safety risks.

Manufacturing 98

Manufacturing Gene Genome Genomics 98

Pharmaceutical Technology

FEBRUARY 3, 2023

As opposed to other therapies or drugs that basically help you manage a condition, gene therapy has the potential to cure a disease,” says Nicole Faust, PhD, General Manager, Cell Line Development, Cytiva. After years of safety-related setbacks and development challenges, recent progress in gene therapy is especially exciting.

Genome 244

Genome Genomics Medicine Gene Therapy 244

pharmaphorum

DECEMBER 23, 2022

The drug was rejected by the US regulator earlier this year a few months after the programme was placed on a clinical hold amid concerns about the drug’s manufacturing, specifically issued related to the possibility of sub-visible particulate contamination from the borosilicate glass vials that were originally used to produce the drug.

FDA Approval 52

FDA Approval Contamination Marketing RNA 52

Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Gene-based therapeutics and vaccines hold immense potential for more efficient and personalised treatment and prevention of complex diseases.

Production 52

Production Gene Protein Vaccination 52

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulators may ask at some point to provide that documentation, so it’s important to track that across the study.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

OCTOBER 7, 2020

FDA regulator and founder of Barragan BioConsulting, where she offers Regulatory and Compliance consulting services to pharmaceutical companies globally. During my presentation, I will discuss about humans as ecosystems and how they pose a source of contamination risk during the manufacture of biopharmaceuticals.

Contamination 52

Contamination Production Manufacturing Compliance 52

XTalks

MARCH 26, 2021

In one lawsuit against Beech-Nut, which sells baby food marketed as “organic” and “natural,” the company is accused of failing to inform consumers about the presence of heavy metals in its baby foods. Currently, the US Food and Drug Administration does not set limits on heavy metals in most baby foods.

Regulation 98

Regulation Manufacturing Contamination Production 98

pharmaphorum

APRIL 6, 2021

AstraZeneca is shifting production of its COVID-19 vaccine away from a plant in Baltimore which also makes Johnson & Johnson’s shot, after human error resulted in the contamination of 15 million doses. . Emergent claims however that one batch of the vaccine simply failed quality controls, and no contamination took place.

Vaccination 64

Vaccination Vaccine Contamination Contract Manufacturing 64

XTalks

MARCH 27, 2023

Earlier this month, the US Food and Drug Administration (FDA) requested $7.2 The extent of the FDA’s problems is reflective of all the different responsibilities the vast agency has, ranging from control and supervision of food safety and cosmetics to pharmaceutical drugs and medical devices. million of the $7.2

Cosmetics 98

Cosmetics Regulation Contamination Drugs 98

Pharmaceutical Technology

MARCH 22, 2023

The demand for injectable drugs is rising. According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. Several drug development trends are driving injectables demand.

Contamination 130

Contamination Packaging Packaging Manufacturing 130

The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. in December 2019; and. in December 2019; and.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

MAY 2, 2023

Free Whitepaper Future-proofing parenteral packaging against nitrosamines During the last five years, pharmaceutical industry regulators have been forced to look closely at the contamination risk of nitrosamines. This whitepaper discusses the issue of nitrosamine contamination since 2018 and the response from regulators and industry.

Packaging 130

Packaging Packaging Production Contamination 130

Pharmaceutical Technology

FEBRUARY 3, 2023

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.

Contamination 130

Contamination Manufacturing Containment Production 130

FDA Law Blog

DECEMBER 14, 2023

The governors (of Colorado, Illinois, Louisiana, Maryland, New Jersey and New York) thanked the President for his leadership in directing the Department of Health and Human Services (“HHS”) to reconsider the current scheduling of cannabis and HHS’ August 2023 rescheduling recommendation to the Drug Enforcement Administration (“DEA”).

Regulation 59

Regulation Production Contamination Drugs 59

FDA Law Blog

FEBRUARY 21, 2023

She also announced denial of three citizen petitions asking FDA to conduct rulemaking to allow CBD products marketed as dietary supplements. The statement explains that risk management tools could include clear labeling, prevention of contaminants, CBD content limits, and age restrictions to mitigate the risk of ingestion by children.

Containment 40

Containment Production Contamination Regulation 40

XTalks

SEPTEMBER 14, 2020

All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. Here again, the stock markets are functioning in a parallel universe. Drugs and Vaccines. billion in June.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92