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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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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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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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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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The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices.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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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pharmaphorum

MAY 5, 2021

The FDA has extended a collaboration with the UK firm CN Bio to investigate a “lung-on-a-chip” model to investigate inhaled drugs. Based in Cambridge, UK, CN Bio has been working with the FDA for four years, which has resulted in the co-publication of an article discussing the performance of the technology.

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European Pharmaceutical Review

JUNE 7, 2024

The first telomerase inhibitor has been approved by the US Food and Drug Administration (FDA). Dr Komrokji remarked that the FDA’s approval of RYTELO (imetelstat) is important because normally, these patients who are transfusion dependent “have very few options” meaning that they “often cycle through available therapies”.

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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 95

European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease.

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The FDA Law Blog

DECEMBER 20, 2023

Tobolowsky — FDA, like much of the rest of the world, has been adjusting to the rapid changes in our world these last few years. On Monday, December 18, FDA announced its most recent update for in-person meetings, and it is one we have been eagerly awaiting. And there we stayed for 6 more months, until now.

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pharmaphorum

MARCH 25, 2022

The FDA views wellness apps as akin to over-the-counter homeopathic treatments—products with minimal risks and low potency – and they are unregulated. The FDA views wellness apps as akin to over-the-counter homeopathic treatments—products with minimal risks and low potency – and they are unregulated. Consistent Standards Matter.

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Pharma Marketing Network

MARCH 27, 2025

In this article, we explore the evolution of social media advertising , why it matters more than ever in pharma, and how marketing teams can stay ahead of the curve. Brands tiptoed around platforms like Facebook or Twitter, fearful of FDA repercussions, adverse event reporting, and lack of clear guidance.

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European Pharmaceutical Review

AUGUST 11, 2023

Novartis said the decision to revoke the authorisation was based on a review of crizanlizumab under Article 20 of Regulation (EC) No 726/2004. Crizanlizumab is approved for use by the United States Food and Drug Administration (FDA). Novartis continues to discuss the STAND results with the FDA and other health authorities.

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The Checkup by Singlecare

DECEMBER 6, 2023

See what articles made the list. Read the full article here. Read the full article here. Read the full article here. Read the full article here. Read the full article here. Read on to see what readers cared about the most in 2023. Did you know that there’s an optimal time window for best results?

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Pharma Marketing Network

DECEMBER 31, 2024

This article breaks down key strategies to help you master pharmaceutical marketing while staying ahead of the curve. Follow FDA guidelines on advertising to ensure your messaging is accurate and ethical. Follow FDA guidelines, ensure accurate messaging, and work closely with legal and regulatory teams to review campaigns.

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European Pharmaceutical Review

APRIL 29, 2024

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. Article: The evolution of AAVs in cell and gene therapy The post Novel haemophilia B gene therapy approved appeared first on European Pharmaceutical Review.

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Pharma Marketing Network

MARCH 19, 2025

This article explores the key metrics pharma marketing teams should prioritize to drive success. Social media analytics should always align with FDA, HIPAA, and GDPR regulations to protect patient privacy and ensure ethical marketing practices. Why is compliance important in social media analytics?

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