STAT

SEPTEMBER 25, 2023

The Food and Drug Administration said Monday that it has deep reservations about NurOwn , an investigational ALS treatment from BrainStorm Cell Therapeutics, citing a lack of evidence that the medicine works and the company’s failure to demonstrate that it can properly manufacture the product.

Documentation 352

Documentation 352

STAT

OCTOBER 20, 2023

The list of AI devices was first published after a STAT investigation reported that the FDA had failed to keep the public informed on its regulation of AI devices, or crucial details on the tests undertaken to prove their safety and effectiveness.

Documentation 314

Documentation 314

Pharmacy Joe

MARCH 27, 2024

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document. appeared first on Pharmacy Joe.

Documentation 98

Documentation Inpatient 98

STAT

JANUARY 20, 2023

Federal Trade Commission asked a federal judge to hold “pharma bro” Martin Shkreli in contempt for failing to provide the agency with information needed to determine whether he is violating an order that permanently banned him from working in the pharmaceutical industry.

Documentation 246

Documentation 246

STAT

MAY 10, 2023

She requests to fill out paper forms instead of digital ones; she documents and tracks what she signs. Alex Rosenblat is particularly careful when it comes to her digital privacy. But even her diligence can’t always save her.

Documentation 243

Documentation 243

European Pharmaceutical Review

FEBRUARY 1, 2023

From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). With CTIS, sponsors can now apply for authorisations in up to 30 EU/EEA countries at the same time and with the same documentation.

Documentation 104

Documentation 104

STAT

AUGUST 1, 2023

Last November, an employee at Intas Pharmaceuticals, which makes several widely used chemotherapies that are in short supply, was seen pouring acetic acid in a trash bin containing documents at a manufacturing facility. Another employee failed to report all test results on product samples and, at times, printouts were tossed in the trash.

Chemotherapy 246

Chemotherapy Documentation 246

FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.”

Documentation 105

Documentation Labelling Communication 105

STAT

SEPTEMBER 26, 2023

The FDA disclosed it has deep reservations about NurOwn, an investigational ALS treatment from BrainStorm Cell Therapeutics, citing a lack of evidence the medicine works and a failure to demonstrate the company can properly manufacture the drug , STAT writes.

Documentation 266

Documentation 266

Putting Patients First Blog

APRIL 30, 2024

General Comments The NHC applauds the FDA’s efforts to enhance the clarity, accessibility, consistency, and an informed consent process that meets the needs of participants. This approach respects the participant’s need for clear and accessible information, which is crucial in aiding their decision-making processes.

Documentation 52

Documentation Communication Mayo Clinic Drug Development 52

Pharmacy Joe

MARCH 27, 2024

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document. appeared first on Pharmacy Joe.

Documentation 52

Documentation Inpatient 52

Express Pharma

JUNE 7, 2023

BASF Pharma Solutions and the Life Science business of Merck KGaA, Darmstadt, Germany announced the launch of a new standard for the electronic transfer of quality and regulatory documentation from suppliers to users in the pharma/biopharma industry.

Documentation 96

Documentation 96

European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

Documentation 98

Documentation Method Validation Packaging Labelling 98

pharmaphorum

MARCH 16, 2021

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. The information was in an email sent in late November by a high ranking EMA official, which outlined a raft of issues.

Vaccines 138

Vaccines Documentation 138

ALiEM - Pharm Pearls

MARCH 29, 2023

These guidelines were made possible by the recent PECARN, Step by Step, and other studies and the invaluable information they have provided [5-7]. Children 29 days or older with fever from a documented viral source can be managed according to their clinical presentation and can go outside the algorithm. Who’s included?

Hospitals 360

Hospitals Documentation Inpatient Immunity 360

Putting Patients First Blog

JULY 1, 2024

General Comments: The NHC commends CMS for its efforts in revising the MPPP model documents to enhance clarity, accessibility, and beneficiary engagement. Additionally, to further enhance the effectiveness of the documents, we recommend the formal establishment of a feedback loop and periodic reviews.

Documentation 52

Documentation Communication Payment Processing 52

National Association of Boards of Pharmacy

MARCH 22, 2024

Food and Drug Administration (FDA) has issued two draft interim guidance documents that address the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Documentation 52

Documentation Compounding 52

ALiEM - Pharm Pearls

JANUARY 26, 2024

Ciprofloxacin has been documented as a cause of IgA vasculitis. Author information Andrew Bleinberger, MD Resident WellSpan York Hospital | The post SAEM Clinical Images Series: A Rare Case of Purpura appeared first on ALiEM. Case Question: What are common triggers for this diagnosis?

Nursing Homes 183

Nursing Homes Documentation Hospitals 183

pharmaphorum

SEPTEMBER 2, 2020

The guidance published on the Medicines and Healthcare products Regulatory Agency (MHRA) website is broadly similar to arrangements laid out in a Brexit “no deal” document published last year. The concern is that UK patients will face delays to receiving the latest medicines because of the changes to the regulatory system.

Documentation 124

Documentation Labelling 124

European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

Documentation 98

Documentation Communication 98

ALiEM - Pharm Pearls

MARCH 3, 2023

During the post-procedure observation period, complete your chart and document your findings, the procedure, whether the patient tolerated the procedure, and any complications while observing your patient and awaiting the final set of vital signs before discharge. PMID 36117013 Author information Gus M. Managing Epistaxis. 2022.07.002.

Documentation 305

Documentation 305

European Pharmaceutical Review

JULY 1, 2022

A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. To overcome these concerns, Pluta presents the process and documentation activities undertaken by one company.

Documentation 105

Documentation Pharmaceutical Manufacturing 105

Express Pharma

MAY 11, 2023

The Income Tax department searched the premises of Mankind Pharma over allegations of tax evasion, informed official sources. The department is searching the company premises in Delhi and nearby locations, documents are being checked and people are being questioned, they said. It also launched its IPO this year.

Documentation 97

Documentation 97

pharmaphorum

JULY 26, 2021

A lack of racial diversity in clinical trials is a long-standing, well-documented problem that contributes to the stark health inequalities that have been brought into sharp focus by COVID-19. It also emerged that informed consent had not been collected. Click here for more information on PhRMA’s health equity programme.

Documentation 116

Documentation Hospitals 116

pharmaphorum

JANUARY 6, 2023

Sponsors running oncology and diabetes trials, for example, will ask for more information on patients’ real-life movements to demonstrate their quality of life, as well as efficacy and safety.”. Teams will develop, review, approve, and track content and documents more closely than ever, right down to version history and user access.

Documentation 111

Documentation Drug Development Diabetes 111

ALiEM - Pharm Pearls

MARCH 8, 2023

Does this come at the expense of your documentation? It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet. It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet. How do you balance your flow with on-shift teaching?

Documentation 147

Documentation Hospitals 147

pharmaphorum

JUNE 8, 2022

Other features include compatibility with Apple’s health data sharing facility, which allows information to be shared securely with healthcare staff or carers, and the ability to export a medications list into a PDF. For example, it can warn of possible issues like mixing drugs like metronidazole or cetirizine with alcohol.

Documentation 131

Documentation Labelling 131

ALiEM - Pharm Pearls

JANUARY 22, 2024

Fever was documented to be 102°F and was not associated with any chills or rigors. Author information Charu Malhotra, MD,MBBS Senior Resident All India Institute of Medical Sciences, New Delhi | The post SAEM Clinical Images Series: Fever with Rash appeared first on ALiEM. View other cases from this Clinical Image Series on ALiEM.

Documentation 161

Documentation Hospitals 161

European Pharmaceutical Review

AUGUST 25, 2023

According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. The document highlights that the revision should also consider related changes in other GMP chapters and annexes as well as in other regulatory documents. What is included in the new revision?

Documentation 98

Documentation Pharmaceutical Manufacturing 98

European Pharmaceutical Review

JULY 4, 2023

The document contains requirements and guidance for testing for bacterial endotoxins. This document relating to microbiological methods is based on ANSI/AAMI ST72. This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both. Why is bacterial endotoxin testing important?

Documentation 111

Documentation Labelling 111

pharmaphorum

FEBRUARY 4, 2021

Over the years, Snapshot has grown into the industry’s most comprehensive toolset for org management, relational data migration, org documentation, technical debt removal, and profile and permission set management. . Documenting this information for every org can greatly improve Salesforce security, governance and compliance.

Documentation 105

Documentation 105

pharmaphorum

NOVEMBER 15, 2021

These must be submitted into the Clinical Trials Information System (CTIS), part of the EU Database, portal, no later than 12 months after the protocol-defined end of the study. The lay summary project, then, fulfils a “current and future need” to provide information in a “transparent, reliable, objective way”. Boosting engagement.

Documentation 98

Documentation Communication Hospitals 98

pharmaphorum

DECEMBER 23, 2021

The guidance gives advice on the design and selection of technologies that are suitable for use in trials, how they can be verified and validated as fit-for-purpose by the sponsor, and the sort of information that needs to be included in an application to start a clinical trial or seek marketing approval.

Documentation 118

Documentation 118

pharmaphorum

JANUARY 26, 2023

The document from the Prescription Medicines Code of Practice Authority (PMCPA) arrives in the wake of several cases where drugmakers made promotional statements on social media platforms – including LinkedIn and Instagram – that were deemed to have breached the code of practice laid down by the Association of British Pharmaceutical Industry (APBI).

Communication 105

Communication Documentation 105

pharmaphorum

OCTOBER 6, 2020

Apply Data: Regulatory employees should be using stored data to intelligently create submission documents. By limiting documents full of free text fields and subjectivity companies can adopt a more digitised approach, where document templates can be compiled automatically from available data.

Documentation 114

Documentation Communication Labelling Data Entry 114

ALiEM - Pharm Pearls

APRIL 5, 2023

Does this come at the expense of your documentation? What is your method for reviewing learners’ notes and how do you provide feedback on documentation? I usually text them if it’s after shift, or talk to them on shift about their documentation. How do you balance your flow with on-shift teaching? Definitely.

Documentation 130

Documentation Hospitals 130

FDA Law Blog: Biosimilars

JUNE 10, 2024

Pre-BIMO Inspection Communication Best Practices The FDA may provide a pre-announcement notice to ensure that the necessary records and personnel are available during the inspection and includes general information about what the FDA plans to review. Submit documentation as evidence of addressing the observations (e.g.,

Communication 111

Communication Documentation 111