FDA Law Blog: Biosimilars

JUNE 5, 2023

Mullen — FDA recently released further updates to the Customer Collaboration Portal (“CCP”). As shown in the screenshot below, the milestones include (i) acceptance decision, (ii) setting the meeting date, (iii) providing written feedback, and (iv) holding the meeting. By Allyson B.

59

59

pharmaphorum

JANUARY 12, 2022

Formedix and CDISC Join Forces to Provide Free Access to Ready-to-Use, CDASH-Compliant eCRFs for Accelerated Clinical Trial Set-Up. We are using the Formedix platform to design CDASH-compliant, example CRFs for the CDISC eCRF Portal ,” noted Peter Van Reusel, CDISC Chief Standards Officer. “We FIND OUT MORE ABOUT RYZE CMDR.

Packaging 52

Packaging 52

pharmaphorum

JUNE 3, 2021

Cognoa thinks its Canvas Dx software as a medical device (SaaMD) could change this, providing an efficient and accurate assessment in primary care that would do away with the need for a lengthy referral to a specialist. “With rapidly-rising autism rates, this crisis will only worsen without new approaches and innovations.”

Communication 114

Communication 114

Amber

DECEMBER 30, 2022

Providers With Us To Experience: More Time for Productivity – Your days are too busy to waste on hold. Customizable Updates – Monitor referrals through email notification, fax notification, or use our provider portal for real-time insight. You deserve a reliable partner. So you know what to expect – every time.

Specialty Pharmacies 52

Specialty Pharmacies 52

Pharma Marketing Network

OCTOBER 14, 2023

It involves the use of digital technology and personalized strategies to improve communication between patients and healthcare providers. It involves the use of digital technology and personalized strategies to improve communication between patients and healthcare providers.

Communication 52

Communication 52

pharmaphorum

JANUARY 19, 2023

The healthcare industry is next, as providers must build digital relationships with their consumers. Healthcare is ready for disruption and artificial intelligence (AI) is ready to assist providers who are struggling to do more with less. The biggest criticism of AI is its dehumanising aspect.

Health and Personal Care Stores 97

Health and Personal Care Stores Communication HIPAA Compounding 97

European Pharmaceutical Review

APRIL 13, 2023

NEW features for 2023 AAPS Collaboration to elevate the educational content at INTERPHEX while providing that important link between science and commercialisation. Read the full press release here >> Innovatech Gateway Pavilion is the portal to global pharmaceutical technologies.

91

91

Digital Pharmacist

SEPTEMBER 13, 2023

Insurance Coverage: Some private insurance plans may offer MTM services to their members, and eligibility criteria may vary among insurance providers. Referral from Healthcare Provider : In some cases, a healthcare provider may refer a patient to MTM services if they believe it will benefit the patient’s health management.

Medication Therapy Management (MTM) 52

Medication Therapy Management (MTM) Communication Community Pharmacies Dosage 52

Putting Patients First Blog

SEPTEMBER 7, 2023

New Report Provides Key Insights on 15 Years of Duchenne Patient-Reported Data September 7, 2023 By: Pat Furlong, President and CEO, Parent Project Muscular Dystrophy (PPMD) September 7 is World Duchenne Awareness Day, a time to raise awareness and inspire action to improve the lives of people living with Duchenne and Becker muscular dystrophy.

Drug Pricing 111

Drug Pricing 111

Pharma Leaders

NOVEMBER 21, 2022

In response, POCN launched a ‘Breast Cancer Center of Excellence’ education portal where advanced care providers can learn from their peers who are experts in the breast cancer specialty treatment area. It offers brand partners a tailored product education area where marketers can reach front-line healthcare providers.

Communication 52

Communication Hospitals 52

pharmaphorum

MARCH 31, 2022

It is couped to Kinesis Gait, a portable clinical tool for quantitative assessment of gait and mobility used during walking tests, as well as a data management portal that provides monitoring and access to patient data.

Hospitals 105

Hospitals 105

Pharmaceutical Business Review

OCTOBER 20, 2023

Aldena CEO Thibaud Portal said: “We are very pleased as Aldena’s agreement with PCI has given us the integrated services and support we need to meet our ambitious research and development timelines. More than 900 million people worldwide suffer from dermatological diseases.

Packaging 52

Packaging 52

European Pharmaceutical Review

JUNE 29, 2023

This approval “provides individuals living with Type 1 diabetes and recurrent severe hypoglycaemia an additional treatment option to help achieve target blood glucose levels,” noted Dr Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research. An extra infusion may be needed, depending on the patient response.

Diabetes 95

Diabetes Adverse Reactions 95

PharmaShots

MAY 19, 2023

Shots: The company has received the US FDA clearance for Assert-IQ ICM that offers long-term monitoring and remote programming to improve connectivity to patients with irregular heartbeats It also provides physicians and users two battery options: a 3yr. battery for traditional cardiac monitoring or 6yr.

40

40

pharmaphorum

NOVEMBER 15, 2022

Indeed, demographics and attitudes towards data privacy aside, there was seen generally a strong willingness to share health data with healthcare providers, as well as with family members. At present, the most-used health apps are those for fitness (46%), patient portal apps (43%), and mental health apps (29%).

HIPAA 130

HIPAA Medical Records 130

pharmaphorum

JULY 27, 2022

Pharma distributor AmerisourceBergen is working on a platform to make access to digital therapeutics (DTx) easier in the US by providing a unified system for ordering, dispensing and fulfilment. It works like this.

Medical Records 72

Medical Records Compounding 72

Express Pharma

JULY 7, 2023

Equity goes beyond equality by addressing systemic barriers and providing fair and just opportunities, resources, and outcomes to individuals regardless of their backgrounds. By enhancing their understanding of the healthcare needs of transgender individuals, we empower healthcare providers to deliver more competent and sensitive care.

Medical Schools 80

Medical Schools 80

Pharma Marketing Network

NOVEMBER 12, 2020

Greystone.Net’s annual Healthcare Internet Conference (HCIC) is the premier conference for healthcare marketing, IT, web, data analytics, business development, public relations and communication leaders who are responsible for their organization’s public-facing websites, intranets, portals, social channels, mobile strategy and CRM strategies.

Communication 52

Communication 52

FDA Law Blog: Biosimilars

JUNE 27, 2023

To provide transparency to industry, and to assist FDA prioritize and conduct its review, FDA should bolster its website to include specific examples of appropriate information to include in voluntary submissions. FDA does not define, however, when information submitted is deemed to be “complete.”

Documentation 59

Documentation Labelling Communication 59

pharmaphorum

NOVEMBER 8, 2022

The Software as a Service (SaaS) platform consists of a wheezo device, app and healthcare monitoring portal, and is used to detect wheeze, a typical symptom of asthma, COPD and other respiratory illnesses, giving an objective measure of airway obstruction.

Hospitals 59

Hospitals 59

RX Note

JULY 30, 2023

Buy yourself some time (if can) to consult various reliable drug references and resources to ensure you have accurate information before providing advice. Avoid giving hasty or potentially incorrect guidance. Seek help from experienced pharmacist if the situation remains unclear.

Hospitals 40

Hospitals Dosage Communication 40

European Pharmaceutical Review

MARCH 2, 2023

EU Clinical Trial Information System From February 2023 all new clinical trials applications must be submitted via the new portal. From February 2023 all new clinical trials applications must be submitted via the new portal. The transition to the new registration system has begun in earnest now.

Drug Development 87

Drug Development 87

pharmaphorum

AUGUST 2, 2022

Australian digital health company Respiri has rolled out its wheezo device, app and healthcare monitoring portal at Michigan Children’s Hospital, the first US customer for the technology. ” The post Respiri brings wheezo device and app to US market appeared first on. .

Hospitals 52

Hospitals Medical Records 52

Express Pharma

MARCH 15, 2024

” The notification directs all associations to constitute an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP), set up a dedicated UCPMP portal on their website, and take further necessary steps towards implementation of the Code.

Pharmaceutical Manufacturing 97

Pharmaceutical Manufacturing Communication Pharmaceutical Companies Pharmaceutical Companies 97

Putting Patients First Blog

JUNE 5, 2023

Other members include health- related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication 40

PharmaShots

JUNE 2, 2023

With private and public health insurance benefits and coverage increasingly subsidizing publicly funded services, healthcare providers can no longer thrive without a proper RCM function, expertise, and technology in place to manage and optimize the financial aspects of healthcare services provided by big, medium, and small-sized organizations.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Health and Personal Care Stores Medical Records Documentation 40

Putting Patients First Blog

AUGUST 2, 2023

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers. Califf M.D.,

Hospitals 40

Hospitals Drug Development 40

Express Pharma

SEPTEMBER 8, 2023

In addition, the system can provide detailed product information, such as manufacturing date, batch number, expiry date, etc., Real-time authentication : The system provides instant verification of pharma packs by scanning image tags using Google Lens and analysing visual patterns with Generative AI. Key features and benefits a.

Packaging 52

Packaging Labelling 52

Pharma Marketing Network

JANUARY 6, 2021

Tools that help people track their health, including apps, wearables, and patient portals will be used more than ever in 2021. This technology enables new tools to provide a deeper level of personalization in healthcare. Trend #2: Location Independence: Virtual Virtuosity. Trend #5: Trust and Wellness: What We Believe and How We Feel.

Communication 98

Communication Vaccines Pharmaceutical Companies Pharmaceutical Companies 98

Pharmaceutical Technology

OCTOBER 28, 2022

While implemented to improve transparency and market competition, this new legislation has caused considerable upheaval for clinical trial providers. Well-versed in providing complex scientific information for regulatory authorities, CTR and RMP lay summaries bring new challenges. Tight turnaround times.

Documentation 52

Documentation 52

The Thyroid Pharmacist

NOVEMBER 29, 2023

You can sign up to access my portal via this page. They have recently updated the portal so that it’s easy for people to use, and easy for me to share protocols with anyone who signs up under me. You can sign up to access my Fullscript portal for free here. Check out the Welldium portal here.

Health and Personal Care Stores 54

Health and Personal Care Stores Immunity Immunization Labelling 54

Viseven

JULY 18, 2023

” By measuring patients’ willingness to recommend a healthcare organization, the NPS provides valuable insights into their level of satisfaction and advocacy. We will examine what NPS provides regarding patient insights, what constitutes a good NPS score in healthcare, and how to effectively calculate and analyze NPS scores.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JULY 29, 2021

Specialty pharmacies now have to be ready to not only meet patient demand, but also provide patients the support they need to secure reimbursement, properly administer the drug, and ensure adherence and optimal outcomes. Using cloud-based technologies, specialty pharmacies have a way to provide comprehensive and on-demand support.

Specialty Pharmacies 111

Specialty Pharmacies Drug Pricing 111

National Association of Boards of Pharmacy

NOVEMBER 8, 2023

ATPs must provide, receive, and maintain lot-level transaction data – the transaction information , transaction history (where required), and transaction statement (also referred to as the “3Ts”) – with each transaction with trading partners.

Packaging 49

Packaging 49

pharmaphorum

NOVEMBER 10, 2022

It provides real-time interpretation of brain scans to specialist and non-specialist clinicians, in order to guide treatment and transfer decisions for stroke patients, allowing more patients to get the right treatment at the right time. Dr Alam added: “In stroke, time is critical.

Hospitals 52

Hospitals Communication 52

pharmaphorum

OCTOBER 7, 2021

That means they are increasingly demanding personalised, relevant, and seamless experiences regardless of how they interact with content providers. Other uses include providing a platform for key opinion leaders (KOLs), as well as internal communications to make sure that messages are unified across an organisation.

Communication 98

Communication Labelling Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

MARCH 31, 2022

Sano also provides bespoke portals to trial sponsors to help them recruit subjects into trials and keep them engaged, for example by providing them with updates on the study’s progress and insights into their own genetic profiles.

Drug Development 52

Drug Development 52