The FDA Law Blog

JANUARY 9, 2025

Here, the FDA investigators documented several instances in which the Quality Manager appeared directly responsible for preventing company employees from talking with FDA about their responsibilities or responding to direct questions from FDA about areas in which FDA has authority to inspect. FDA Guidance , at 8 (emphasis added).

FDA

Hospital Pharmacy Europe

AUGUST 13, 2025

Follow-up interviews were held with respondents who reported using such systems, and available prioritisation documents were analysed. The researchers interviewed 16 staff who reported using prioritisation systems, and 11 institutions provided prioritisation documents for analysis.

Documentation

European Pharmaceutical Review

DECEMBER 2, 2024

Considering its numerous benefits, such as the above, regulators therefore encourage drug manufacturers to use mass spectrometry together with ELISA analysis, or mass spectrometry analysis by itself, for control and documentation of product impurities, explained Alphalyse.

Documentation

Pharma Manufacturing

JULY 14, 2025

Out of 202 Complete Response Letters issued between 2020 and 2024, 150 involved quality/manufacturing issues, according to the regulator’s newly released documents.

Documentation

STAT

APRIL 13, 2025

In an unusual move, an audit of commercial health plans by Tennessee officials found that Express Scripts, one of the largest pharmacy benefit managers in the United States, violated state laws in its dealings with pharmacies, according to newly released documents.

Specialty Pharmacies

European Pharmaceutical Review

FEBRUARY 3, 2025

The document identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. Inadequate validation of test methods : KVK-Tech failed to establish and document the accuracy, sensitivity, specificity and reproducibility of test methods.

FDA

Drug Topics

AUGUST 8, 2025

4 Artificial intelligence (AI) systems are quickly evolving to assist with diagnosing health problems, tailoring drug therapy, and completing clinical documentation. Shortages of physicians and nurses in primary care will lead to more opportunities for pharmacists to deliver health care services beyond medication dispensing.

Specialty Pharmacies

STAT

MARCH 7, 2025

  UnitedHealth acquired full or partial ownership stakes in more than 100 surgery centers in 2024, according to a STAT review of UnitedHealth’s newest annual financial documents.

Health Insurance Companies

European Pharmaceutical Review

JUNE 19, 2025

Document 9286/25. The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. Brussels: Council of the European Union; 2 June 2025. Interinstitutional File: 2023/0131 (COD).

Packaging

Blog: Ask a Student Pharmacist

AUGUST 13, 2025

As the student gains comfort and proficiency, they will perform a limited number of clinic visits and documentation with increasing amounts of independence. Students will document cases in the Poison Center database. Students will document their patient care activities in the electronic medical record.

Patient Care

Pharma Tutor

AUGUST 9, 2025

Dates for the CBT, Document Verification and Medical Examination will be communicated from time to time through the official websites of the concerned RRBs. The link for submission of the online application will be made live on these websites.

Documentation

STAT

JANUARY 7, 2025

The brief, 20-page document, instead, focuses on AI models used to produce data that supports regulatory decision-making about the safety, effectiveness, or quality of drugs. The guidance does not, however, capture how AI is being used in drug discovery, the process of identifying and designing molecules, or in operational efficiency.

FDA

The FDA Law Blog

JULY 8, 2025

Per FDA’s update, non-application products without annual report requirements should prepare similar documentation and retain it for FDA inspection requests.

FDA

PQA

JUNE 26, 2025

While clinical services represent the future, the practical challenge of documenting these encounters threatens to impede progress. This documentation burden isn't just inefficient; it's a barrier to success. They want to understand the what and the how of the interventions that close gaps in care.

Documentation

Hospital Pharmacy Europe

AUGUST 6, 2025

AI roles across the infectious disease diagnostic pathway AI is driving tangible improvements in diagnostic and documentation workflows, potentially enhancing speed, accuracy and scalability in both laboratory and clinical settings. However, one particular message was abundantly clear: AI is not a shortcut.

Documentation

Hospital Pharmacy Europe

DECEMBER 17, 2024

Right documentation. CLMM ensures that, across all stages of the process from prescription to bedside administration, including medication preparation, dispensing and distribution the six rights of medication administration are met: 1. Right patient 2. Right medication 3. Right dose 4. Right time 5. Right route 6.

Hospitals

SingleCare

JULY 7, 2022

Having a written pharmacy drug recall policy and procedure document in place for all staff members can help ensure a smooth process, especially if an FDA inspector decides to verify any recalled drugs at your pharmacy. However, in many cases, the FDA requests or mandates that a drug is recalled.

Documentation

European Pharmaceutical Review

JULY 15, 2025

The data challenge The research reveals a stark reality: 80 percent of pharmaceutical organisations surveyed report serious problems with either the availability or quality of data and documentation. “There was definitely a perceived risk of changing the ways of working practices.

Documentation

Hospital Pharmacy Europe

JUNE 26, 2025

Within the UK, pharmacists generally lead on SACT protocol development and are the authors of these important medicines information documents – with the MDT, clinicians and nurses reviewing the content.’

Patient Care

Viseven

MARCH 11, 2025

Effortless document copying with “Edit in eWizard” Our team ensured version accuracy for the localization copy with the MLR-approved content item. Content creators can now be 100% sure that they are working on an approved version of the document without worrying about creating duplicates and accidentally working on an old version.

Documentation

PharmD Live

JULY 1, 2025

Without documented patient consent: Claims can be denied Medicare reimbursement is forfeited Practices face potential audits, penalties, or disqualification from CMS programs Trust between providers and patients erodes These consequences are what no executive or practice manager can afford to ignore.

HIPAA

Pharma Marketing Network

JULY 18, 2025

Smarter MLR Workflows Review cycles that once took weeks can now be accelerated by AI-based content tagging and document comparison tools. AI tools assist in document comparison, regulatory tagging, and claim validation to speed up MLR processes while reducing compliance risks. How does AI help with compliance in pharma marketing?

HIPAA

Drug Topics

JULY 1, 2025

Pharmacists can get trained credentials, get up to speed and enrolled to generate $20, $30, $50 a month per patient in managing their medications a little better and documenting it.

Health and Personal Care Stores

STAT

JANUARY 7, 2025

The advent of the first generic GLP-1 drugs could help Medicare negotiate a lower price for the highly sought after diabetes and obesity medication semaglutide , according to experts familiar with the price-negotiation program and STAT’s review of documents from the first round of negotiations.

Documentation

DiversifyRx

MARCH 27, 2025

Ask for EIN, 501(c)(3) documentation, and referencesbut know that these can even be faked. Vague mission or unverifiable charity status. Pressure to ship immediately. Payment by credit card only. Here’s How To Protect Yourself If it smells fishy, trust your gut and say no. Never ship before verifying that the payment is legitimate.

Inventory Audits

Drug Topics

JUNE 11, 2025

The study cohort included 670 patients who were diagnosed with PsA of at least a 3 month duration and have active plaque psoriatic skin lesions or a documented medical history of plaque psoriasis. READ MORE: Significant Knowledge Gap Exists in Patient Awareness of Psoriatic Disease The study found that 54.2%

Specialty Pharmacies

Hospital Pharmacy Europe

JULY 23, 2025

This, in turn, requires structured documentation, such as dedicated fields in electronic prescribing systems, where prescribers can specify critical preferences like flavour, texture or excipient restrictions, to ensure that each patient receives a safe and personalised formulation.

Hospitals

Pharmacy Times

AUGUST 11, 2025

Because documentation of medication lists is a key component of MTM, pharmacists are well positioned to incorporate this into transitions of care.” Community pharmacists significantly impact these transitions through medication reviews at the point of dispensing and during medication therapy management (MTM) encounters.

Hospitals

Pharmaceutical Commerce

JUNE 18, 2025

27 of this year to meet the requirements, as long as they are making documented efforts to finalize data connections, of course. In fact, wholesalers and repackagers had until May 27, 2025 (following this day, full-unit traceability would be mandatory), a date that has officially passed.

Specialty Pharmacies

Pharmacy Times

AUGUST 15, 2025

When a nonpreferred product is clinically necessary, she recommends that clinicians include clear documentation supporting the rationale for that choice to help expedite prior authorization.

Immunization

European Pharmaceutical Review

JUNE 12, 2025

Data traceability and immutability : meticulously documenting metadata pertaining to data sources, quality and context, to provide AI applications with the necessary contextual information during data processing. Also, this aspect is crucial for interpretable results.

FDA

Therapeutics Education Collaboration

AUGUST 1, 2025

Perhaps they feel alone and that other people are not working on reducing medications Show Notes The Mechanics of Tackling Overprescribing and Problematic Polypharmacy Health Innovation Network (HIN) document which includes the evidence base, the car analogies, and practical advice for both clinicians and care boards/systems Health Innovation Network (..)

Documentation

PharmTech

JUNE 6, 2025

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals.

Dosage

Drug Topics

AUGUST 8, 2025

Throughout the study period, pharmacists were tasked with patient consultations, working with other providers to enhance patients’ treatment plans, and documenting the evidence-based results to use for future care. They conducted a total of 498 anti-effective therapy consultations and met with a total of 313 patients (58.8%

Specialty Pharmacies

Pharmacy Times

AUGUST 15, 2025

Documentation and reporting of errors and near misses should be used to identify areas for improvement to prevent future occurrences. Organizations are responsible for creating policies and procedures that provide a safe and supportive environment, supplying resources and training, and proactively addressing system vulnerabilities.

Communication

Pharmacy Times

JUNE 9, 2025

Pulmonary function tests and provider documentation were manually reviewed to confirm asthma diagnoses, while individuals with other pulmonary diseases were excluded. 1 The study also observed that 65% of patients had a documented visit with an asthma specialist during the follow-up period.

Compounding Pharmacies

Pharmacy Times

JUNE 20, 2025

Other documented causes of secondary dysmenorrhea include fibroids, adenomyosis, infection, myomas, obstructive reproductive tract anomalies, and ovarian cysts About the Author Yvette C. Dysmenorrhea, also known as painful menstruation, is the most commonly reported menstrual symptom among females during the reproductive years.

Compounding Pharmacies