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By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).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

pharmaphorum

JANUARY 20, 2022

It informs companies how its content is created, approved, reused and published and how to optimise performance for a more significant impact. Now, content strategies can be informed and realistic expectations for progress can be defined.”. The information companies provide in their content has to be accurate.

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European Pharmaceutical Review

MAY 11, 2023

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. The paper is intended to initiate communication with stakeholders, including industry and academia, to foster mutual learning and discussion.

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European Pharmaceutical Review

OCTOBER 17, 2023

The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications. Fundamentally, this approach will establish whether facilities meet applicable requirements for FDA approval and licensure decisions.

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Pharmaceutical Technology

DECEMBER 11, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The post US FDA grants Fast Track status for Pfizer-BioNTech’s combination vaccine appeared first on Pharmaceutical Technology.

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Pharma Marketing Network

MARCH 8, 2025

It must convert visitors into leads , provide clear and accurate medical information , and ensure compliance with FDA, HIPAA, and ad platform policies. Patient Awareness: Helps provide disease information, medication adherence tips, and support program details. Compelling and Compliant Headline Clearly communicate value (e.g.,

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HIPAA FDA Communication 59

pharmaphorum

JUNE 3, 2021

The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after it was filed for approval. It also includes a healthcare provider portal that can be used to enter answers to questions about behaviour, track information provided by caregivers, and review results.

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Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. While in the US, the therapy is already being prescribed under an expanded access program , the FDA has requested additional data from a randomised, placebo-controlled trial before it will allow Egetis to schedule a PDUFA date. on placebo.

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pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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Pharma Marketing Network

MAY 27, 2025

Patient influencers are uniquely positioned to bridge the gap between clinical information and lived experience. They speak in relatable terms, build trust, and often foster inclusive communities. All content, branded or not, must comply with FDA, FTC, and local market guidelines. However, challenges abound.

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Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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Pharma Marketing Network

DECEMBER 4, 2024

Companies are investing heavily in digital tools to streamline communication and build stronger connections. Strategies like storytelling, personalized educational content, and two-way communication channels create trust and build loyalty. Patient-Centric Marketing Patients want to feel heard.

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The FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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Pharmaceutical Technology

JANUARY 24, 2023

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

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pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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Pharma Marketing Network

MARCH 11, 2025

However, with so much information available, finding the right resources can feel overwhelming. Platforms like Salesforce Health Cloud and Veeva Systems help teams organize data, automate communication, and improve relationship management. Staying informed about industry trends and best practices is essential for long-term success.

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The FDA Law Blog

MAY 14, 2025

Schwartz In early April, Cellares became the first company to announce receipt of an Advanced Manufacturing Technology (AMT) designation from FDA. 356l), directed FDA to establish the AMT Designation Pilot Program. The law directed FDA to issue guidance regarding the implementation of the program, which was finalized in December 2024.

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Pharmaceutical Technology

JANUARY 31, 2023

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Moderna ’s investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) in adult patients. In August 2021, the US FDA granted Fast Track designation to mRNA-1345.

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pharmaphorum

JULY 19, 2022

Speaking during a Patients as Partners meeting, Ebony Dashiell-Aje, senior director of patient engagement and outcomes research at BioMarin Pharmaceuticals, said these small, informal, non-regulatory events helped the FDA “better understand what is most important” among specific patient groups. The rise of patient centricity. “We

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The FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). FDA also requests a “detailed description of the allegation with any available supporting documentation.”

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pharmaphorum

AUGUST 24, 2020

In the United States, the 21st Century Cures Act encouraged the Food and Drug Administration (FDA) to review and communicate patient experience data from trials – but the lack of a common framework for submissions and space on product labels has, until now, been something of a stumbling block. .

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STAT

JULY 27, 2023

Settling on the right approach took years of research and testing, which resulted in the name Opill and packaging featuring bright teal, saturated pink, and yellow, as well as a rounded font reminiscent of millennials’ ubiquitous favorite Gotham.

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European Pharmaceutical Review

MARCH 5, 2024

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. This was communicated in a Letter to Industry (medical devices) published by the agency on 20 February 2024.

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The FDA Law Blog

MARCH 7, 2024

In 2006, FDA stated that DMCs were not recommended “for most clinical studies,” particularly those in early product development, short-term studies, or studies addressing less severe outcomes. Increased Connections Between a DMC and FDA? However, in contrast to DMCs, such an entity should remain blinded to efficacy data.

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Pharmaceutical Technology

JANUARY 16, 2023

The US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to the company’s zevor-cel in 2019. In October last year, CARsgen submitted a new drug application (NDA) for CT053 to China’s National Medical Products Administration (NMPA).

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Pharma Marketing Network

APRIL 28, 2025

Additionally, regulatory bodies like the FDA are encouraging patient-focused communications, further legitimizing this trend. Thus, marketers will need to communicate outcomes and cost-benefits with more clarity than ever before. It will play a role in verifying drug information, supply chains, and even ad tracking.

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ISPE

MAY 22, 2023

Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the World Health Organization (WHO); and Joyce Cirunay, Director IV of the Center for Drug Regulation and Research at the Philippines FDA. Companies interested in participating in the survey can send an email to regulatory@ispe.org.

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Communication FDA 98

PharmExec

JULY 7, 2023

Newly-issued final guidance focuses on language used when communicating quantitative efficacy or risk information.

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Pharma Marketing Network

APRIL 21, 2025

With increasing pressure from regulatory bodies and rising media costs, pharma marketers are rediscovering the power of personalized communication. Importantly, consistency in tone and branding across all pharma communications boosts credibility. Email offers direct, personalized communication with HCPs and patients.

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The FDA Law Blog

NOVEMBER 29, 2023

Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions. FDA considers these guiding principles as complimentary to their recent efforts around PCCPs including their proposed draft guidance on PCCPs.

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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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The FDA Law Blog

SEPTEMBER 22, 2024

The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ).

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Pharmaceutical Technology

JANUARY 31, 2023

The gene therapy received Orphan Drug and Fast Track designations from the US Food and Drug Administration (FDA). It includes a recombinant AAVrh10 vector that expresses a micro ribonucleic acid (miRNA) which reduces the expression of SOD1 to slow down or reverse ALS progression in SOD1 mutation patients.

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Communication FDA 111

The FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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The FDA Law Blog

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. By Véronique Li, Senior Medical Device Regulation Expert & Deborah L.

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The FDA Law Blog

AUGUST 11, 2024

on July 17, 2024 for a social media post published by Instagram influencer Brittany Mahomes (who has 2 million Instagram followers) about AUVI-Q (epinephrine injection, USP) that “entirely omit[ed] all risk information” about the drug. FDA notes in its letter that it received multiple complaints about the website under its Bad Ad Program.

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