The FDA Law Blog

MARCH 21, 2024

Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. The MoCRA rollout, though, does not preclude that FDA may practice some regulation by enforcement if it deems such action necessary.

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pharmaphorum

SEPTEMBER 29, 2022

A digital patient monitoring tool developed by UK company CyberLiver has been given a breakthrough designation by the FDA for out-of-hospital management of patients with cirrhosis at risk of complications. The post Digital tool cuts hospital readmissions in cirrhosis patients appeared first on.

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Hospitals Communication FDA 52

Omnicell

JANUARY 10, 2023

This trend is likely to continue with specialty medications expected to account for 65 percent of drug spending by 2025. Namely, there are currently more than 400 new cell and gene therapies under development, and 60 percent of the new molecular entities awaiting FDA approval are specialty pharmaceuticals.

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Pharmaceutical Technology

MAY 2, 2023

Memo Therapeutics has announced that the FDA has awarded a fast track designation for its BK polyomavirus (BKV) drug AntiBKV (MTX-005). This FDA decision was based on data from the Phase I Safe Kidney I clinical study (NCT05358106). Memo expects to potentially launch AntiBKV in 2025.

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FDA Communication 52

Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). DBV expects to share topline data from the study in H1 2025.

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The FDA Law Blog

JUNE 7, 2023

the Medicaid Drug Rebate Agreement and the Medicare Part D Coverage Gap Discount Agreement or the agreement under the successor Part D discount program that begins in 2025), Merck characterizes that as a coercive penalty for the refusal to forfeit its First and Fifth amendment rights.

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Pharmaceutical Technology

JUNE 19, 2023

Planning, planning, planning, using validated shippers, ensuring robust packaging processes, and communicating product specifications to ensure as many variables as possible are accounted for is the key to success,” he continues. “A

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ISPE

SEPTEMBER 8, 2023

In addition, this article provides an explanation of the purpose and expected outcomes from the survey, subsequent plans for communicating the results from the survey across ISPE, and development of concrete proposals to address the sources of challenges and barriers to innovation. 22 June 2023. 22 June 2023. EMA/321483/2020. 3 July 2020.

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ISPE

NOVEMBER 2, 2022

Strategic plan refresh for 2023–2025 involved an adaptation from the existing strategic plan, with the Society taking a “very confident position: Shaping the Future of Pharma and bringing quality medicines to patients worldwide.”. The initiative provides growth incentives for local groups and benefits the Society overall.

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Documentation Compounding Communication FDA 52

pharmaphorum

APRIL 19, 2022

Kim says the Dry Eye Disease market is large and growing, with analysts predicting it will hit $6 billion USD by 2025. I think the most important thing is making a good team and also good communication within that team is very important. RudaCure’s key differentiators. Everyone in our team is very valuable,” he said. “I

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Pharmaceutical Companies Pharmaceutical Companies Communication FDA 52

IDStewardship

APRIL 14, 2024

Candidate 2025 Mentored by: Christina G. These advancements are evidenced by the two FDA-approved FMT products available for rCDI prevention: Rebyota (Fecal Microbiota, Live-jslm) and Vowst (Fecal Microbiota Spores, Live-brpk). Rebyota, a solution delivered via enema, was the first FMT product to be FDA-approved. Gut Microbes.

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The FDA Law Blog

JULY 7, 2024

Unfortunately, the guidance for small entities recently published by FDA is little more than a summary digest of the multi-hundred-page final rule. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements. 803), Reporting of Corrections and Removals (21 C.F.R. § 820.198).

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Labelling FDA Communication Documentation 64

Pharma Marketing Network

JANUARY 7, 2025

Because the way your company communicates its value to patients, healthcare providers, and stakeholders can mean the difference between success and failure. This article explores top strategies that can help you lead with confidence and achieve executive success in 2025. Why does this matter? So, how can you strike a balance?

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Communication FDA Patient Care Vaccines 52

The FDA Law Blog

JUNE 14, 2023

In the ever-changing landscape of medical device development, FDA is touting steps it is taking that it says will enhance efficiency, foster innovation, and address key challenges faced by developers. It remains to be seen how FDA would define and actually implement the role of a TAP Advisor.

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The FDA Law Blog

JULY 9, 2024

To encourage the development of such guidance, Congress directed FDA to issue a draft guidance not later than 12 months after the date of FDORA’s enactment and to finalize such guidance not later than 9 months after closing the comment period. Sponsors may discuss DAPs with FDA sooner. intended use population. role in global health.

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FDA Communication Documentation Labelling 59

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Wireless medical devices.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Wireless medical devices.

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Health and Personal Care Stores FDA HIPAA Communication 52

ISPE

SEPTEMBER 11, 2023

Nature Communications 12, no. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.raps.org/news-and-articles/news-articles/2023/3/fda-official-warns-manufacturers-of-common-problem 25 US Food and Drug Administration Center for Drug Evaluation and Research. Biotechnology Progress 36, no.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

Pharmaceutical Technology

MARCH 22, 2023

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. From 2025, it will be substituted with a new chapter on functional tests for the complete system.” The demand for injectable drugs is rising.

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Pharmaceutical Technology

JANUARY 20, 2023

The CEO illustrated his point, by discussing that in June, the Center for Biologics Evaluation and Research (CBER), at the FDA, requested new vaccines for the BA.5 Construction will start in early 2023, and the UK plans to produce the first mRNA vaccine there in 2025. 5 Omicron variant.

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IDStewardship

DECEMBER 11, 2024

With Twitter changing to X in mid-2023 and subsequently in the end of 2024 many folks from the IDtwitter community moving over to Bluesky, the game is certainly ever-changing. I wonder if this will cause us to be more fragmented as a group in 2025 and if Bluesky will really have sticking power. Mastodon sure did not.

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The FDA Law Blog

FEBRUARY 26, 2025

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. How will the cuts at FDA impact inspections and enforcement? Clarity of purpose is a good place to start. Dialogue is also key.

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Communication FDA 66

The FDA Law Blog

MARCH 30, 2025

Livornese & Ricardo Carvajal On March 18, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched a significant initiative called Operation Stork Speed to bolster the availability and safety of infant formula in the United States ( link , link ). By Charles D.

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Pharma Marketing Network

APRIL 3, 2025

This article dives deep into how patient marketing has changed, whats driving this transformation, and what strategies are leading the way for 2025 and beyond. The Digital Transformation of Patient Marketing Technology has revolutionized how pharma communicates with patients. How has patient marketing changed in recent years?

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HIPAA Communication Packaging Pharmaceutical Companies 52

European Pharmaceutical Review

APRIL 2, 2025

11-13 Recent reports from US Food and Drug Administration (FDA) authors concluded that AI can usefully be applied to some aspects of ICSR (individual Case Safety Reports) processing and evaluation, but the performance of current AI algorithms requires a human-in-the-loop to ensure good quality. FDA Discussion Paper And Request For Feedback.

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The FDA Law Blog

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R.

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The FDA Law Blog

FEBRUARY 20, 2025

Gibbs The multi-decade battle over FDAs power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. Despite this impending massive change in regulatory scope, the President and his Department of Government Efficiency (DOGE) fired hundreds of FDA employees this past weekend. By Allyson B.

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