RX Note

JUNE 11, 2025

The Five Essential Steps Collect subjective and objective information about the patient to understand the relevant medical/medication history and clinical status of the patient. Without addressing these key issues, even well-informed individuals are unlikely to follow medical advice.

Documentation

RX Note

JUNE 11, 2025

The Five Essential Steps Collect subjective and objective information about the patient to understand the relevant medical/medication history and clinical status of the patient. Without addressing these key issues, even well-informed individuals are unlikely to follow medical advice.

Documentation

FDA Law Blog: Biosimilars

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. This can limit the type of information that can be gained from WLs. See 21 C.F.R.

Documentation

Express Pharma

JULY 21, 2025

He noted frequent gaps in team understanding due to staff turnover and stressed the need for strong communication, confidentiality, and documentation practices. He also underlined the importance of safeguarding proprietary information and avoiding unauthorised process changes.

Documentation

Drug Patent Watch

JANUARY 15, 2025

While Google Patents is a widely used tool for searching patent information, it may not be the most effective solution for identifying drug patents. Understanding Google Patents Google Patents is a search engine that allows users to search the full text of patent documents from around the world.

Documentation

Express Pharma

JANUARY 10, 2025

The Ministry of Electronics and Information Technology has released the draft Digital Personal Data Protection Rules 2025 (Rules) for public consultation and stakeholder feedback. These Rules aim to support the implementation of the Digital Personal Data Protection Act 2023 (DPDPA) which received presidential assent on August 11, 2023.

Documentation

ALiEM - Pharm Pearls

JANUARY 10, 2025

Other documented pharmacological causes of anisocoria include nebulized ipratropium bromide and scopolamine (14-19). Author information Dominique Gelmann, MD Resident Physician Wake Forest University Emergency Medicine Residency | The post SAEM Clinical Images Series: A Curious Case of Anisocoria appeared first on ALiEM.

Documentation

European Pharmaceutical Review

JUNE 19, 2025

Advances in analytical science, combined with the EMA’s regulatory experience, have shown that CES often do not provide additional meaningful information when the biosimilar and RMP are already well-characterised. Document 9286/25. Brussels: Council of the European Union; 2 June 2025. Interinstitutional File: 2023/0131 (COD).

Biosimilars

Express Pharma

MARCH 16, 2025

Indian companies will need to enhance their quality control mechanisms, data management systems, and documentation practices to comply with these demanding standards. For patient-centric innovations to succeed, patients must be informed about their options and the benefits of personalised treatments.

Biosimilars

Express Pharma

JUNE 11, 2025

For drug discovery teams, messy data creates a ripple efFect, leading researchers to de- sign experiments and build models based on flawed assumptions or incomplete information, ultimately wasting valuable resources. Harmonisation without proper data cleaning is like building on quicksand—fragile and unsustainable.

Data Entry

Beckers Hospital Review

AUGUST 1, 2025

. “AI is not just coming for healthcare — it’s already here ,” said Sunil Dadlani, executive vice president and chief information, digital and cybersecurity officer of Morristown, N.J.-based based Atlantic Health System. “Human skill sets must move up the value chain,” he said.

Documentation

STAT

MARCH 3, 2025

posted a document  proposing to strip public participation from much of the business his department conducts , STAT writes. Hims, which offers compounded versions of Novo Nordisk’s Wegovy, drew criticism from some lawmakers for omitting safety information about the customized medicines in its advertisement. Kennedy Jr.

Compounding

Express Pharma

FEBRUARY 12, 2025

“It is not justifiable to compare pharma products, where a lot of work has already been done and well-documented with international harmonisation (e.g., “Ethical marketing focuses on education rather than exaggeration, empowering consumers with accurate information about product benefits.

Documentation

Express Pharma

AUGUST 12, 2025

” Main Purpose Regulatory application/ submission management A public database listing all FDA-approved small molecule drugs (not biologics) and providing information about equivalence, patents. Indian innovators would benefit from clear public information on patent life and exclusivity, incentivising high-value R&D investments.

Documentation

Fuld & Company Blog

AUGUST 20, 2024

Some examples include: Development of target lists for business development: Using Gen-AI/LLM to scour high volumes of company, market and transactional information from proprietary databases to generate high quality, relevant target lists for marketing, empowering business development teams.

Documentation

pharmacy mentor

JUNE 23, 2025

This also allows patients to understand what medications they are taking and provide that information to other medical professionals if necessary. This is great as it allows prescribers to provide extra information about treatments and facilitates communications even when someone needs information out of hours.

Health and Personal Care Stores

RX Note

DECEMBER 25, 2024

Information that should remain confidential includes the following: Patient's identity and address Diagnosis Details of prescribed and non-prescribed medicines To illustrate, we should not publicly discuss a patient's condition with another colleague or customer when the patient has just left the community pharmacy.

Community Pharmacies

RX Note

AUGUST 13, 2025

Read and document refrigerator and freezer temperatures at least twice each workday (in the morning and before the end of the workday). An example of a buffered probe is one immersed in a vial of liquid (e.g. This prevents false readings due to the rapid changes in air temperature that occur when refrigerator doors are opened.

Drug Storage

Putting Patients First Blog

APRIL 8, 2025

6 ,7 One of the most critical ethical considerations is informed decision-making. 12 When AI- generated outputs inform clinical decisions, there must be clear lines of responsibility among developers, clinicians, and manufacturers. Also important is the need for clearly defined and delineated accountability.

Documentation

European Pharmaceutical Review

JUNE 12, 2025

Also, consistency across data sources should be taken into consideration; one should not fear having heterogeneous sources, yet it is crucial to afford the model a way to understand information in a cohesive and consistent way. This relates also to data discontinuity. There are pockets of very rich data and pockets of very sparse data.

Drug Development

RX Note

DECEMBER 25, 2024

AHFS Drug Information Australian Medicines Handbook British National Formulary Micromedex Lexicomp Medscape Aronoff's Drug Prescribing in Renal Failure, 2007 Drug Prescribing in Renal Failure focuses on drug dosing in patients with impaired kidney function.

Dosage

Drug Patent Watch

JANUARY 8, 2025

Proactive measures to protect your patents include: Regular patent portfolio reviews Monitoring competitor activities Maintaining detailed lab notebooks and documentation Implementing strong trade secret protections By staying vigilant, you can often prevent infringement before it occurs or strengthen your position if litigation becomes necessary.

Pharmaceutical Companies

European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

Documentation

Express Pharma

JANUARY 3, 2025

Data integrity and documentation: The need for accurate and reliable data is paramount. Regulatory bodies require strict documentation and data tracking without any discrepancies. Non-compliance can result in severe penalties, recalls, and damage to a companys reputation.

Documentation

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. Companies must adhere to HIPAA regulations and inform users about AI-driven personalization. However, when implemented responsibly, AI acts as a creative partner—not a replacement.

HIPAA

Express Pharma

MAY 22, 2025

Features like eCOA libraries with prebuilt instruments and the ability to autogenerate code and documentation accelerate development without sacrificing quality. With role-based permissions, dashboards and workflows are accessible to team members and offer data insights needed to inform clinical decisions appropriate for their given role.

Documentation

National Association of Boards of Pharmacy

JULY 23, 2025

We have found that some pharmacies’ patient profiles contain incomplete information, with critical elements missing. If a pharmacy is not collecting all required patient information, any drug utilization review (DUR) performed by the pharmacist will be incomplete.

Adverse Reactions

Express Pharma

FEBRUARY 17, 2025

With 66 per cent of healthcare firms already piloting GenAI, we are seeing significant traction in areas like medical documentation, diagnostics, and revenue cycle management. Regulatory compliance and data privacy concerns remain key barriers due to the sensitive nature of medical and patient information.

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. ” The benefits extend beyond efficiency gains.

Pharmaceutical Manufacturing

Pharmacy Joe

JULY 23, 2025

While PPI-related adverse effects are well documented in the general population, evidence that describes these adverse effects in patients with chronic kidney disease is limited. This study represents important information related to PPI use in the subgroup of patients with chronic kidney disease.

Diabetes

PharmExec

AUGUST 7, 2025

Embedding information security and privacy-by-design principles into AI and data platforms. The issue of AI hallucinations—generating convincing but false information—underscores the need for hybrid models where AI augments and assist human reviewers rather than replaces them. It means data is: Structured and standardized (e.g.,

Communication

European Pharmaceutical Review

APRIL 15, 2025

EMA also encouraged companies to liaise with regulators and submit any information as needed. Furthermore, they suggested including new radiopharmaceuticals in horizon scanning activities.

Documentation

Putting Patients First Blog

APRIL 21, 2025

Safety and information in new cities by providing a list of emergency care services. Accessibility tools on event sites and transitioning from PDF to Word documents for meeting agendas. Attention to dietary needs to ensure attendees feel supported. Utilizing outdoor spaces for conference activities. Fragrance-free areas.

Documentation

Putting Patients First Blog

APRIL 14, 2025

The proposal to eliminate the automatic 60-day extension for providing income verification documentation could result in disenrollment of eligible individuals unable to promptly produce required documentation.

Insurance Coverage and Processing

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.” This education can significantly impact patient outcomes, as informed patients are more likely to follow their prescribed treatment plans and avoid complications that could lead to readmissions.

Medication Therapy Management (MTM)

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.

Drug Pricing

Putting Patients First Blog

JUNE 26, 2025

Greater visibility into these rebate trends could enable oversight of affordability trends, foster more informed public discourse, and allow patients and advocates to better anticipate the evolving cost burden on the Medicare program. This will allow other stakeholders (e.g.,

Drug Pricing