pharmaphorum

JUNE 11, 2024

The FDA is exploring ways to transform the home into a healthcare hub, bringing healthcare services closer to individuals. This article discusses the potential impact of this trend on the future of healthcare.

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FDA 116

IDStewardship

APRIL 14, 2024

In this article a comparison of Rebyota versus Vowst is provided, to help learners differentiate these two fecal microbiota therapies. Article Posted 14 April 2024 What is Clostridioides difficile ? Rebyota, a solution delivered via enema, was the first FMT product to be FDA-approved. Authored by: Natalie Boyer, Pharm.D.

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Fierce Pharma

JANUARY 6, 2024

A group of cell therapy experts, including CAR-T pioneers Drs. Bruce Levine and Carl June, wrote in support of continued use of CAR-T therapy.

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FDA 117

IDStewardship

OCTOBER 27, 2022

In this article an infectious diseases pharmacist discusses antibiotic myths. Article posted 27 October 2022. Here is an article in BMJ that details the topic. ” New antibiotics coming to the market must have a reasonable degree of safety and efficacy to achieve FDA-approval. Authored by: Timothy P. BCPS, BCIDP.

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Labelling FDA 364

Pharmacy Times

OCTOBER 21, 2024

Non–FDA-approved medications may be accessed for patient care via 3 alternative pathways: expanded access, the Right to Try Act, and off-label use, which are reviewed in this article.

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The FDA Law Blog

MARCH 19, 2023

s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy. Hyman, Phelps & McNamara, P.C.’s

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STAT

JUNE 29, 2024

First Opinion is STAT’s platform for interesting, illuminating, and maybe even provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.

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FDA 126

The FDA Law Blog

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

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Documentation FDA 119

pharmaphorum

FEBRUARY 22, 2024

Discover how AI, automation, and blockchain technologies are revolutionising pharmaceutical case processing in compliance with FDA regulations. Explore the benefits of these advancements in this insightful article.

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FDA 116

pharmaphorum

JANUARY 11, 2024

The FDA is overseeing significant changes in R&D IT as it shifts towards advanced modalities and biologics. Learn more about these exciting developments in this article. This includes the emergence of CRISPR-Cas9 gene editing technology and its potential impact on diseases like sickle cell anaemia.

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FDA 122

European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. The FDA’s regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials.

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pharmaphorum

DECEMBER 19, 2023

This article explores the growing interest and recent developments, including FDA approvals and the potential impact on the pharmaceutical industry. Big pharma companies like Pfizer are making significant investments in antibody-drug conjugates, a promising class of therapies.

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FDA 115

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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Pharma Marketing Network

MARCH 28, 2025

From navigating HCP engagement strategies to optimizing branded content under FDA oversight, the articles are far from generic. The article “How Has Social Media Advertising Changed in Pharma” explores not only emerging formats but also the risks of engagement without proper oversight. Stay curious. Stay informed.

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FDA 59

STAT

APRIL 23, 2024

So judging the FDA’s accelerated approval program without assessing its full impact on overall survival presents a very slanted story. Overall survival is usually considered the gold standard in oncology because people with cancer generally want to take medications that can help them live longer.

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FDA 118

The Checkup by Singlecare

DECEMBER 26, 2024

Over 40 new medications have been approved by the FDA, giving patients more options for treating various health problems. Zelsuvmi (berdazimer) Zelsuvmi received the green light from the FDA on January 5, 2024. Zelsuvmi’s approval is a big deal because it’s only the second FDA-approved treatment for this condition.

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pharmaphorum

JULY 21, 2022

Now FDA on-site inspections have resumed, with regulatory authorities returning to physical sites. Throughout the pandemic, the lack of FDA inspections has created new challenges and heightened existing problems, largely due to delays in upgrading legacy facilities. Upgrading facilities. Ensuring GMP readiness.

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STAT

AUGUST 9, 2023

This article was adapted from STAT’s latest report , “Failed trial, successful drug: how a negative readout can still lead to FDA approval.”

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FDA 96

The Checkup by Singlecare

DECEMBER 7, 2023

But because they’re dietary supplements, they’re not regulated by the FDA. In this article, we look at five red flags to watch for controlled medication abuse and how to approach the issue with compassion. The post Read the top 5 health articles for pharmacists in 2023 appeared first on The Checkup. Read more here.

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Med Ed 101

SEPTEMBER 18, 2024

In this article, we will highlight some of the differences and similarities between Neffy and Epipen. Neffy was approved for patients who weigh over 30 kg or more by the FDA in August of 2024. […] The post Neffy Versus EpiPen – Clinical Comparison appeared first on Med Ed 101.

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FDA 93

The Checkup by Singlecare

MARCH 18, 2025

Note that while there are compounded versions of tirzepatide and semaglutide , these drugs are not FDA approved. This article focuses on the five FDA-approved versions of tirzepatide and semaglutide. Tirzepatide is the active ingredient in two medications approved by the Food and Drug Administration (FDA).

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Labelling FDA Insurance Coverage Insurance 52

The People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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Pharma Marketing Network

MARCH 11, 2025

Strict guidelines from the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) require marketers to ensure transparency and accuracy in all communications. FDA Guidelines and Promotional Review Committees Understanding FDA regulations is critical for all pharma marketing professionals.

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HIPAA Communication FDA Insurance 52

The FDA Law Blog

JANUARY 16, 2025

While HPM prides itself on being the largest dedicated FDA law firm in the United States, it is small by design, so it is the quality of each of these individuals and what they contribute to the firm that is most exciting, said HPM managing Director J.P. She already has broad-based exposure to a variety of FDA regulated products.

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FDA 59

STAT

FEBRUARY 20, 2025

We also talk about Elaine’s latest article on the push for greater and greater weight loss from obesity drugs, along with developments at Solid Biosciences and federal job cuts. We discuss all that and more on the latest episode of “The Readout LOUD.” Read the rest…

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FDA 70

Pharma Marketing Network

DECEMBER 4, 2024

In this article, we’ll explore 10 innovative trends in pharma marketing that can set you up for success in this rapidly evolving landscape. Adhering to guidelines from the FDA and other governing bodies ensures that campaigns remain effective without crossing ethical boundaries. Learn more about compliance tips at Pharma Marketing.

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The FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Labelling FDA Communication 64

European Pharmaceutical Review

DECEMBER 21, 2022

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. EMA and FDA have given prime importance to the whole genome sequence characterisation of the strain in the final product dossier.

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Documentation FDA 111

The Checkup by Singlecare

MARCH 10, 2025

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. In this article, well take a closer look at semaglutide, its costs, and alternatives that may be offered. Learn more from our article on how to get Wegovy covered by insurance. Does insurance cover Ozempic?

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Compounding Insurance Insurance Coverage FDA 52

The Honest Apothecary

APRIL 24, 2023

Here I share some of the latest news, articles, editorials, or blog posts that fall generally under the theme of Pharma or healthcare. All article shared will be free to read and not locked behind an annoying paywall. NEW FDA WARNING: OPIOIDS MAY INCREASE PAIN! ” CAL-MATTERS. This is interesting.

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STAT

AUGUST 17, 2024

First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.

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FDA 106

Pharma Marketing Network

MARCH 6, 2025

This article explores effective social media advertising strategies tailored for pharmaceutical marketing executives , helping them navigate compliance and create impactful campaigns. HCP Engagement Share clinical studies, drug updates, and thought leadership articles to build credibility.

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HIPAA FDA 52

The FDA Law Blog

DECEMBER 12, 2022

Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA). Please check out FDA’s presentation on this very topic – Is My Product a Medical Device?

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Documentation FDA Communication 23

pharmaphorum

SEPTEMBER 29, 2022

Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. When assessing mHealth technology, the FDA will determine whether an application is either: i.

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FDA Documentation 104

pharmaphorum

JUNE 14, 2022

Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval. China’s ambition to become a leader in the biopharma industry has been clear in the last few years.

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STAT

JANUARY 25, 2024

The FDA has been looking into 22 cases of T-cell cancers that occurred after treatment with CAR-T, Reuters notes, citing an article published in The New England Journal of Medicine by two FDA officials. Ozempic and similar diabetes medicines have been increasingly used off label for weight loss.

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European Pharmaceutical Review

OCTOBER 7, 2024

Data from this Phase II supported US Food and Drug Administration (FDA) approval: a 98 percent response rate and an 83 percent complete response rate. Researchers from this first real-world study of the cell therapy explained that outcomes are comparable to the results of the CARTITUDE-1 trial.

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FDA 105