Communication, Document and FDA - Pharmacy Technician Pulse

Pharma Marketing AI: Doing More With More

Pharma Marketing Network

JULY 18, 2025

Furthermore, personalization now extends to patient-facing communications. Smarter MLR Workflows Review cycles that once took weeks can now be accelerated by AI-based content tagging and document comparison tools. It’s helping them do more with more —more data, more insight, more precision, and more human impact.

HIPAA

HIPAA Documentation Communication Dosage

Pharmacist to Clinical Strategy Leader: Brendan Doran on Building a Career in Biotech

The Nontraditional Pharmacist

JULY 1, 2025

What are the regulatory constructs that the FDA puts out in front of you to get there? And then how do you develop documents to basically get approval from the FDA to study your drug in humans? There’s a lot of other aspects that go along with it, but at a high level that’s roughly what that was.

FDA

FDA Hospitals Packaging Documentation

The Value of a Medically Integrated Pharmacy to Maximize Cost Avoidance and Reduce Waste of Oral Oncolytic Medications

Pharmacy Times

JUNE 17, 2025

If a discrepancy is found, the pharmacy nurses will hold the shipment, and a clinical intervention will be communicated to the provider. During this time frame, the pharmacy documented 152 interventions. Results American Oncology Network (AON) Pharmacy collected data on waste and cost avoidance from February 2023 to September 2023.

Mail-Order Pharmacies

Mail-Order Pharmacies Compounding Pharmacies Medical Records Dosage

George Tidmarsh to sub in as FDA CBER head following Prasad’s shock exit

Pharmaceutical Technology

JULY 31, 2025

Annabel Kartal Allen July 31, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The FDA has appointed George Tidmarsh as the temporary director of CBER after Vinay Prasad’s sudden exit. Image credit: -Oxford- via Getty Images. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate?

FDA

FDA Packaging Communication Hospitals

Corticophobia Can Significantly Impact AD Management Strategies

Drug Topics

JULY 8, 2025

TCSs are the first-line anti-inflammatory treatment and their effectiveness and safety have been well documented.” The next step consists of treatment with topical anti-inflammatory therapies. Above all other medication classes and formulations, TCSs have been deemed as the most important pharmacotherapy in the treatment of AD.

Vaccines

Vaccines Specialty Pharmacies Compounding Communication

How ICH E6 (R3) is changing clinical trials

Pharmaceutical Technology

JULY 24, 2025

Integrated CDMS solutions also facilitate smoother communication and coordination between stakeholders, enabling faster, data-driven decision-making – all increasingly crucial for maintaining oversight and regulatory compliance. To explore how Zelta can support your organization’s clinical data management needs, download the document below.

Communication

Communication Packaging Documentation FDA

The GLP-1 Gold Rush: Why Compounded Alternatives Are a Risky Bet

Pharmaceutical Commerce

JULY 16, 2025

However, in the context of GLP-1s, this often means creating versions of FDA-approved drugs when those drugs are either unavailable or prohibitively expensive, raising critical questions about their regulatory oversight, safety, and effectiveness. Simply put, they bypass this standard FDA pathway.

Compounding

Compounding Insurance FDA Compounding Pharmacies

Secrets of Pharmaceutical Market Access

Pharma Marketing Network

MAY 9, 2025

This article uncovers the hidden elements of market access success, revealing what it takes to move from FDA approval to formulary inclusion, provider buy-in, and patient adoption. Tools and Partnerships That Enhance Access Market access success isnt just about what you presentits how you communicate it. What is an AMCP dossier?

Packaging

Packaging Documentation Communication FDA

Top 10 RPM Vendors 2025: Driving Results in Remote Patient Monitoring

PharmD Live

JUNE 23, 2025

PharmD Live’s board-certified clinical pharmacists manage and monitor the RPM service, record and document patient health metrics, and provide monthly billing reports, reducing provider workload without sacrificing care. Smith’s primary care provider, discontinued the problematic medication, and initiated a safer pain management plan.

HIPAA

HIPAA Documentation Hospitals FDA

Research Suggests Vitamin D Deficiency Is a Risk Factor for Autism

Pharmacy Times

JULY 9, 2025

Autism Spectrum Disorder (ASD) impacts social communication, behavior, and daily functioning. SHOW MORE Discover how vitamin D supplementation may reduce Autism Spectrum Disorder symptoms and improve overall functioning in children with ASD. 4 Despite promising findings, evidence remains mixed.

Compounding Pharmacies

Compounding Pharmacies Immunization Specialty Pharmacies Compounding

Supporting the pharmaceutical industry – how a CDMO can help

European Pharmaceutical Review

JULY 9, 2025

This collaborative approach enabled us to implement customised aseptic processing simulations and establish comprehensive documentation for API traceability before production began. Consider their communication approach, project management capabilities, and how they handle unexpected challenges—because there will be challenges.

Documentation Vaccines FDA Pharmaceutical Companies

Cell and gene therapy: The vital role of logistics

Pharmaceutical Technology

JULY 2, 2025

For gene therapy in the US, there are eight FDA-approved oncologic treatments, with prices ranging from $65,000 to $475,000. In addition, documentation of the material is required, along with clearly defined next steps for modification and expansion. However, costs can soar even higher. Sign up for our daily news round-up!

Packaging

Packaging Compounding Communication FDA

From Pasteur to Present: Historical and Contemporary Perspectives on Publication Bias in Scientific Literature

Pharmacy Times

JULY 29, 2025

Geison’s The Private Science of Louis Pasteur provides a historical framework for examining long-standing patterns in scientific communication, particularly the divergence between experimental practice and published narrative.

Department of Veterans Affairs

Department of Veterans Affairs Communication Vaccines Compounding Pharmacies

GSK’s Blenrep US comeback hindered by eye safety concerns

Pharmaceutical Technology

JULY 16, 2025

Robert Barrie July 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Shares in London-listed GSK closed 1.19% down following the document release. Robert Barrie July 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Shares in London-listed GSK closed 1.19% down following the document release.

Documentation FDA Communication Packaging

Sino Biopharma spends $951m to acquire China-based LaNova Medicines

Pharmaceutical Technology

JULY 15, 2025

The net payment made by Sino to acquire LaNova will be approximately $500.9m, a figure that excludes the estimated cash and bank deposits, according to a company document outlining the terms of the transaction. At the time, Sino spent 142 million yuan ($19.80m) to initiate its ownership involvement with the biotech.

Packaging

Packaging Communication Hospitals Vaccines

Can rare disease research in the US thrive under the new administration?

Pharmaceutical Technology

JULY 18, 2025

As one FDA initiative works to sustain the momentum of rare disease research, other events threaten to slow progress. Manasi Vaidya July 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Credit: [H_Ko]/Shutterstock.com In 2024, 50% of the novel drugs approved by the FDA had an orphan drug designation.

FDA

FDA Packaging Communication Hospitals

Significant Knowledge Gap Exists in Patient Awareness of Psoriatic Disease

Drug Topics

JUNE 11, 2025

READ MORE: FDA Approves Roflumilast Foam For Plaque Psoriasis of Scalp, Body The current treatment guidelines for patients with psoriasis include a variety of pharmacological options, such as biologics, phototherapy, and topicals. of the population across the region,” wrote authors of the study.

Immunization

Immunization Documentation Specialty Pharmacies Compounding

Day by day, how Trump is roiling science and health

STAT

APRIL 24, 2025

HHS pauses CDC, FDA, and NIH communications with the public. In a sign of the reach of Trump’s orders to eliminate DEI initiatives, the FDA removes information on ensuring clinical trials are diverse from its website. Trump administration starts rehiring fired FDA workers after pushback from industry.

Vaccines

Vaccines FDA Documentation Communication

GSK’s Blenrep faces setback as FDA cancer committee votes against approval

Pharmaceutical Technology

JULY 18, 2025

Abigail Beaney July 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep. The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the 23 July PDUFA date.

FDA

FDA Communication Packaging Hospitals

From data to impact: How real-world evidence will transform healthcare

pharmaphorum

JULY 7, 2025

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued clear guidance for incorporating RWE in regulatory submissions, labelling expansions, and post-market monitoring. Previously, she held multiple leadership roles at Forrester, including VP and research director, and VP principal analyst.

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies Documentation Labelling

More on the Impact of the FDA RIFs: How Information Disclosure will Start FOIA-lling Behind

The FDA Law Blog

APRIL 10, 2025

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. However, not all information contained in FDA records is disclosable. However, not all information contained in FDA records is disclosable.

FDA

FDA Documentation Packaging Communication

European biotech ecosystem takes aim at changing the funding narrative

Pharmaceutical Technology

JUNE 17, 2025

Having a long-term partner, who can help build an ecosystem for the long term help, and this has been well documented in the US, he added. He cited the example of VIB’s work with Belgian biotech argenx to develop an asthma treatment, ARGX-118, which argenx will now further develop. Sign up for our daily news round-up!

Communication

Communication Hospitals Packaging Documentation

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

The FDA Law Blog

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). If FDA agrees to the PCCP, such changes can be made without a supplemental marketing submission.

FDA

FDA Documentation Labelling Method Validation

Top AI Tools for Pharma Marketers: Boosting Compliance, Content, and Customer Engagement

Pharma Marketing Network

MAY 23, 2025

In practical terms, this means fewer legal escalations, faster campaign launches, and improved documentation for FDA or EMA audits. Conclusion AI is transforming the way pharmaceutical companies communicate, educate, and engage. Are AI tools compliant with FDA regulations?

FDA

FDA Documentation Pharmaceutical Companies Pharmaceutical Companies

To Meet or Not to Meet: Day 70 and Counting

The FDA Law Blog

JULY 17, 2025

Newberger — Recent communications from CDRH indicate that impacts to resources from Reductions-In-Force are causing some Offices in CDRH to delay granting a request for a pre-submission (or Q-Submission) meeting until after written feedback is provided. By Véronique Li, Senior Medical Device Regulation Expert & Jennifer D.

FDA

“Radical Transparency” and “Deregulation” from Trump and RFK Jr.’s FDA. Unless it’s Useful to the Device Industry

The FDA Law Blog

MAY 23, 2025

Newberger Last week, FDA published a Request for Information (RFI) ( here ) seeking input from the public on its efforts to to identify and eliminate outdated or unnecessary regulations. Industry relies on guidance documents to understand the Agencys current policy and practice. By Allyson B. Mullen & Jennifer D.

FDA

FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

The FDA Law Blog

SEPTEMBER 16, 2024

Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.

Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

The FDA Law Blog

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In FY2023, FDA conducted over 1000 inspections under the BIMO program. We also detail some of our recommended best practices to achieve success when FDA comes knocking.

FDA

FDA Communication Documentation

FDA suggests ways to curb constraints with rare disease gene therapy trials

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.

FDA

Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

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.

FDA

FDA Documentation Packaging Communication

How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

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. In another update, the recent draft guidance added “entities reviewing safety data” and adaptation committees.

Documentation FDA Adverse Reactions Communication

It’s the Law Now –Cybersecurity Information in Premarket Submissions

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. It applies whether the software is the entire device (i.e.,

Documentation FDA Labelling Communication

Helping FDA Help Itself: Voluntary Submissions of Allegations of Regulatory Misconduct

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

FDA Documentation Labelling Communication

FDA staff appear to support Biogen’s ALS drug despite limited data

Pharmafile

MARCH 21, 2023

It appears that the FDA is inclined to support Biogen’s amyotrophic lateral sclerosis (ALS) drug, tofersen, with documents released on Monday stressing the need for “regulatory flexibility” when assessing treatments for life threatening diseases such as ALS. read more

FDA

Minor Updates to FDA Pre-Submission Guidance With More to Come

The FDA Law Blog

JUNE 20, 2023

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. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.

FDA

Considerations for Mobile Health Technology Developers: Part 2

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.

FDA

FDA Documentation Labelling Communication

ISPE Represented at PIC/S 50th Anniversary Event

ISPE

NOVEMBER 23, 2022

Continue active cooperation with strategic partners , encourage PIC/S membership and strengthen PIC/S communications and engagement. Build PIC/S operational capacity by securing new revenue streams, implementing fiscally sound financial plans and increase transparency to the PIC/S community.

FDA’s Pre-Cert Pilot Ends. Will there be a Sequel?

The FDA Law Blog

OCTOBER 31, 2022

Lenz, Principal Medical Device Regulation Expert — FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). As part of the pilot program, FDA included a Test Plan. By Adrienne R.

Overview of FDA Expedited Development and Approval Programs for Serious Conditions

Impact Pharmaceutical Services

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Image courtesy of qimono at pixabay.com.

FDA

The Good, Bad, and Ugly side of 510(k)s—HP&M’s Early Experience with the eSTAR Template for 510(k)s: Part 2

The FDA Law Blog

MARCH 7, 2023

If multiple people are reviewing and need to communicate changes it may be challenging to ensure all updates are incorporated. Lack of compatibility with cloud-based document sharing. Creation of unnecessary documents. There is no option to reference a document that has already been attached elsewhere in the submission.