The FDA Law Blog

NOVEMBER 17, 2022

Koblitz — As was introduced in our recent blog post summarizing the 2022 MedTech conference ( here ), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot ( see announcement attributed to CDRH director Jeff Shuren, M.D.,

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The FDA Law Blog

NOVEMBER 21, 2022

The TAP Pilot is intended to “de-risk the medical device valley of death,” the metaphorical place where innovative technologies die while trying to reach the market. By Adrienne R. here ), Federal Register notice ( here ) and the Program Website ( here )). here ), Federal Register notice ( here ) and the Program Website ( here )).

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Communication FDA 59

pharmaphorum

OCTOBER 12, 2022

Sustainability for Injectable Delivery Devices. Connected Drug Delivery Devices. This event will not only bring you key insights you need to expand and enhance your injectable device portfolio but will also give you the opportunity to network with key players throughout the industry. Primary Packaging Development.

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Packaging 52

pharmaphorum

JUNE 16, 2022

Jennifer discusses how Abbott has approached these issues in the clinical trials for their vascular medical devices. They discuss the nitty-gritty of clinical trial diversity – why it’s been so hard to achieve, why it’s important, and how to overcome the specific barriers to inclusion for different underrepresented communities.

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Pharmaceutical Technology

DECEMBER 27, 2022

Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. Drug pricing was a hot-button topic, and William Newton found that while e-commerce chains could cut insulin prices , any major change won’t happen overnight. See you in 2023!

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Vaccines 122

The FDA Law Blog

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. By Adrienne R.

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The FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP).

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pharmaphorum

SEPTEMBER 21, 2020

Amazon’s Alexa device can already field health and medical questions, but the library of responses has now been bulked up thanks to a partnership with digital health company Sharecare. billion at the end of 2018, according to market research. billion at the end of 2018, according to market research.

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The FDA Law Blog

FEBRUARY 26, 2024

Walsh among an elite panel discussing “Around the World Hot Topics” – a session dedicated to exploring recent enforcement trends, regulator expectations, and best practices in white-collar crime law. With over 26 years of dedicated service to the pharmaceutical and medical device industries, Ms.

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FDA 59

OctariusRx

MARCH 27, 2023

This week we discuss the implications of the new guidelines on injection practices and medication safety. Below is a list of the newest core practices related to injections and medications. Use aseptic techniques when preparing and administering medications. Is your facility fully compliant?

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Clinic Management 66

pharmaphorum

FEBRUARY 25, 2021

Drug Delivery Devices Symposium. We have the distinct privilege of unveiling Oxford Global’s Drug Delivery Devices Symposium, taking place on the 10th of March, 2021. Attendees should not miss out on panel discussions on critical topic areas such as International Perspectives on Regulatory Pathways & Device Design and Engineering.

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The FDA Law Blog

NOVEMBER 30, 2023

The speaker faculty of top FDA regulatory authorities will share critical insights on foreign and domestics inspections, digital health, DOJ’s compliance guidelines, and data privacy, among many other topics. The conference will also include its annual panel discussion with FDA’s Center Compliance Directors.

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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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The Checkup by Singlecare

MAY 11, 2023

Pharmacists can have a significant impact on women’s health by providing education, counseling, and medication management services. Medication management : Through dispensing and clinical monitoring, pharmacists play a vital role in ensuring women receive appropriate medications and dosages. What is women’s health?

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The FDA Law Blog

JUNE 22, 2023

Mullen — FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. Companies are also experiencing significant regulatory obstacles with another related category: home collection devices. Cato & Jeffrey N. Gibbs & Allyson B.

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PharmaShots

MAY 5, 2023

The expo is targeting medical and healthcare tech's brightest brains and thought leaders in the middle east and around the world. The key takeaways from the event are: Gain insights and understanding of where the medical sector is heading in the near future. Meet and connect with industry peers to collaborate in future endeavors.

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Roots Analysis

FEBRUARY 22, 2024

These wounds heal naturally without requiring any medical attention, with the majority of them healing within the 3 to 6 weeks. Therefore, they require specific medical attention to return to normalcy. These devices address the limitations associated with advanced wound care dressings and bioengineered skins and dermal substitutes.

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ISPE

OCTOBER 27, 2022

Emerging digital health technologies (DHTs) may improve the quality of life for patients with chronic and debilitating diseases and provide novel health care solutions for patients with unmet medical needs. What Is Digital Health? Table 1: Terms and definitions for DHTs. Description. Artificial intelligence (AI)/machine. learning (ML).

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ISPE

OCTOBER 27, 2022

Emerging digital health technologies (DHTs) may improve the quality of life for patients with chronic and debilitating diseases and provide novel health care solutions for patients with unmet medical needs. What Is Digital Health?

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Health and Personal Care Stores FDA HIPAA Communication 52

Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Shares in Futura Medical rose following the FDA nod – opening 28% higher than the previous day’s (June 9) close.

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FDA 52

pharmaphorum

MARCH 15, 2022

Using information garnered from hundreds of patient sessions conducted by leading pharmaceutical and medical device companies, Within3 recommends five best practices for asynchronous virtual patient engagement: Choosing the right participants – both patients and moderators. Tips for conducting blind or double-blind sessions.

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ISPE

SEPTEMBER 15, 2023

The Regulatory, Compliance, and Quality sessions, promise to be a comprehensive exploration of the vital topics shaping the pharmaceutical landscape. Advanced therapies within combination products represent a frontier where pharmaceutical innovation meets medical technology.

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The FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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ISPE

OCTOBER 28, 2022

According to ISPE Combination Products Communities of Practice Chair Susan Neadle, “a combination product is composed of two or more differently regulated medical products, i.e., constituent parts, that are to be used together, or are being studied for use together, to achieve an intended use, indication, or effect.

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Hospital Pharmacy Europe

MAY 25, 2023

Operating alongside the MHRA’s existing Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices, the new venture forms part of a long-term vision for more personalised medicine approaches. Other topics of focus for the pilot phase will be confirmed in due course.

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pharmaphorum

NOVEMBER 17, 2021

SMi Group’s 14 th Annual Conference and Exhibition: Pre-Filled Syringes and Injectable Drug Devices 2022 – 12 th – 13 th January 2022. Sustainability for Drug Devices Focus Day – 14 th January 2022. The Future of Drug Delivery and Combination Product Device Design. London, UK www.pre-filled-syringes.com/Pharmaphorum.

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Packaging 52

pharmaphorum

SEPTEMBER 4, 2020

Topics of discussion will include the latest updates on the EU MDR and Article 117, advances in novel drug products and biologics, parenteral packaging for pre-filled syringes, innovations in device design and platforms for combination products, lifecycle management and much more…. Pre-Filled Syringes and Injectable Drug Devices.

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Packaging 52

The People's Pharmacy

MAY 4, 2023

Ditto for other monitoring or measuring devices. A device that reads consistently above or below the true value could lead to over or under treatment of hypertension. Devices were considered validated if reported as such on any validation listings and nonvalidated if they were not on any lists.” We could not agree more!

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Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. What are pharmaceutical medical affairs? . What do medical affairs teams do? .

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The Checkup by Singlecare

OCTOBER 9, 2023

For many, Benadryl ( diphenhydramine ) is one of those over-the-counter medications that is always kept on hand. Just because there is a line of brand name Children’s Benadryl products—and Benadryl use in kids is a common practice—doesn’t mean all children can or should take the medication.

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ISPE

JUNE 15, 2023

™” applies to all life sciences products including pharmaceuticals, medical devices, and hybrid products, as well as equipment and systems facilitating development and production of activities. The life sciences regulatory and guidance environment is evolving as industry moves into the Pharma 4.0™ ™ paradigm.

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The FDA Law Blog

JUNE 20, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

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pharmaphorum

AUGUST 31, 2022

Futura Medical’s development of a topical treatment for erectile dysfunction (ED) is approaching the finish line in the US, as the UK biotech reports confirmatory phase 3 data ahead of an FDA filing later this month. ” The post Futura eyes FDA filing as topical ED drug passes phase 3 test appeared first on.

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FDA 52

The Checkup by Singlecare

MARCH 14, 2024

Continue reading to learn more about this topic. Before taking ibuprofen, you should tell your healthcare provider about all of your medical conditions. When certain medications are taken with ibuprofen, there is an increased risk of bleeding. NSAIDs like ibuprofen are associated with an increased risk of bleeding.

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The Checkup by Singlecare

FEBRUARY 15, 2023

If you experience difficulty breathing, stomach cramping, headache, lightheadedness, swelling of your face, tongue, or hands, or chest tightness, seek emergency medical care. If the hives are accompanied by other symptoms such as swelling of the face, tongue, or hands, and shortness of breath, you should seek immediate medical attention.

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Immunization 105

BuzzRx

OCTOBER 14, 2022

Please continue reading to find out more about human drug compounding and compounded medications. In other words, while most pharmacies simply dispense pre-made medications, compounding pharmacies make customized medications that are not available from commercial drug manufacturers. Why did my doctor prescribe compounded drugs?

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The Checkup by Singlecare

MARCH 6, 2023

Over-the-counter medications can be taken without a prescription, but it is still possible to overdose on these drugs. Benadryl , an antihistamine used for a variety of purposes in adults and children, is a common over-the-counter medication that has been in the news lately because of something called “ the Benadryl challenge.”

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