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 Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” It applies whether the software is the entire device (i.e., Software in a Medical Device, or SiMD).

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pharmaphorum

SEPTEMBER 28, 2020

The FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health devices, software and wearables to create medical products.

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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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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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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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XTalks

JANUARY 27, 2023

Nobelpharma America, a pharmaceutical and medical device company headquartered in Bethesda, Maryland, has launched an educational website called Face Forward. “Face Forward is an excellent complement to the medical information offered on the TSC Alliance website and is a welcome additional resource to our community.”

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Clinical Trial Podcast

JUNE 6, 2021

Simply stated, you need a clinical and regulatory strategy when it comes to conduct of clinical trials for medical devices. In this episode, Priya shares with us her experience and knowledge on regulatory affairs, specifically focused around medical device regulations in the United States.

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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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Scienmag

SEPTEMBER 23, 2021

Due to the trend of miniaturization of devices, micromanipulation has been a hot topic in the last two decades. For instance, in medical cardiac catheterization, if physicians don’t know the exact contact force between […].

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WCG Clinical

APRIL 3, 2023

Princeton, NJ, April 3, 2023 : WCG Clinical announces the relaunch of its publication FDAnews, a trusted resource for pharmaceutical and medical device insights for more than 50 years. The post WCG Clinical Announces Relaunch of FDAnews as the Premier Source for Drug and Device Insights appeared first on WCG Clinical.

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Pharmaceutical Technology

JUNE 10, 2023

Its product portfolio includes pharmaceutical products such as anti-allergic agents, anti-tumor agents, H2 receptor antagonists, antibiotics and medical devices; and consumer health products such as herbal digestive medicine, topical analgesics, antifungal cream and herbal medicine powder, among others.

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Pharmaceutical Technology

JUNE 10, 2023

Its product portfolio includes pharmaceutical products such as anti-allergic agents, anti-tumor agents, H2 receptor antagonists, antibiotics and medical devices; and consumer health products such as herbal digestive medicine, topical analgesics, antifungal cream and herbal medicine powder, among others.

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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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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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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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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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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 Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

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FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

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Camargo

MAY 2, 2021

These therapies frequently target diseases in patients that are rare (affecting fewer than 200,000 people in the US), serious, and representing an unmet medical need. Discuss new delivery devices, early product development, and/or pre-clinical proof-of concept. Scope and Topics: INTERACT vs Pre-IND Meetings. Product selection.

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Pharmaceutical Technology

MAY 12, 2023

NYBC Ventures will focus on investment in therapeutics, devices and new technologies to address issues in benign haematology, transfusion medicine and infectious disease. Topic sponsors are not involved in the creation of editorial content. The New York Blood Center (NYBC) has provided the investment for the inaugural fund.

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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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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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XTalks

DECEMBER 20, 2023

These advancements and trends addressed important industry challenges and offered opportunities to foster innovations and solutions in areas including drug development, healthcare and medical devices. Bayer’s Astepro (azelastine), an over-the-counter medication for cold, flu and allergies, led the pack in the first half of 2023 with 7.4

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Life Science Clinical Trials Clinical Trials FDA Approval 59

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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XTalks

MARCH 25, 2021

Each week, host Sydney Perelmutter will be joined by editorial team members, Mira Nabulsi, Ayesha Rashid and Sarah Hand to discuss trending food industry topics and share insights from industry experts. Sydney writes about various food industry topics, including safety and regulation, grocery and foodservice, innovation and sustainability.

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VirTrial

FEBRUARY 28, 2024

Topic 1: Modular implementation in phase III, and meeting the needs of all stakeholders Even though we collect data remotely in multiple other therapeutic areas, oncology is not one where we routinely see this employed, so that brings with it the technologies, techniques, and methodologies for remote data collection.

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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.

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Rethinking Clinical Trials

AUGUST 3, 2023

As researchers, we are producers and consumers of the medical literature. It is important to understand that there are different standards depending on the topic. If you’re not prepared to see your manuscript appear in a leading medical journal, you should think carefully before posting it as a preprint.

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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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Pharma Packaging Solutions

SEPTEMBER 26, 2019

We have plenty of new things to talk about including sustainable packaging – this seems to be a hot topic and we are your sustainability packaging partner. And the always hot topics of serialization and aggregation are open for discussion. If you need to kit or carton a medical device, we are also happy to help you.

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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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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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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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Drugs Drug Delivery Engineer Production 52

Imperical Blog

MAY 4, 2021

Corporate purchasing departments scrambled to be first in line to acquire the required PPE, medical ancillary supplies, and electronic and medical devices to keep their businesses afloat. The sourcing of medical commodities by global region based on the latest COVID-19 data became a true strategy to survive.

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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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