STAT

APRIL 11, 2024

Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer have projected — according to a document obtained by STAT.

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Documentation 145

The FDA Law Blog

SEPTEMBER 16, 2024

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. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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Documentation FDA Communication 59

STAT

JULY 23, 2024

CVS Caremark, one of the largest pharmacy benefit managers in the country, agreed to pay at least $45 million to the state of Illinois to settle allegations that rebates were not passed through during a recent four-year period, according to a document obtained by STAT.

Documentation 145

Documentation 145

STAT

AUGUST 5, 2024

As documented in a recent commentary that I and several colleague published in the journal Frontiers in Research Metrics and Analytics, considerations of diversity, equity, and inclusion (DEI) have been introduced into federal science funding decisions. Each of the major U.S. Read the rest…

Documentation 145

Documentation 145

STAT

OCTOBER 23, 2023

Starting in the first quarter of 2024, Optum’s post-acute-care companies will be called Home & Community Care, according to internal documents obtained by STAT. However, Optum advised employees that “Home & Community Care should not be directly next to the Optum logo” in marketing materials.

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Documentation Patient Care Hospitals Insurance 145

STAT

MARCH 18, 2024

CVS Caremark, the PBM owned by CVS Health that oversees the prescription drug benefits of 103 million people, told its employer clients that it anticipated “more lower-cost products (including specialty biosimilars) may become preferred products” on its lists of approved drugs for 2024, according to documents obtained by STAT.

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Documentation Pharmaceutical Companies Pharmaceutical Companies Insurance 145

Fierce Healthcare

MARCH 18, 2024

. | Following a single-hospital pilot, the nonprofit health system will roll out Regard’s tool in a phased approach to all 33 acute-care hospitals in its system across six states in 2024. The technology is an opportunity to increase facetime between providers and patients, the partners say.

Documentation 75

Documentation Hospitals 75

OctariusRx

FEBRUARY 20, 2024

The 2024 controlled substance assessment quiz is about to be released! you know that not following proper processes and poor documentation can lead to patient harm and/or large fines from regulatory agencies, such as the United States Drug Enforcement Administration (DEA). How are you assessing your staff? Contact us for assistance.

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Controlled Substances Documentation 76

STAT

MAY 20, 2024

A huge amount of those documents were released last week, and the numbers mirror what  we’ve been seeing over the past several months : Not all hospitals are in dire straits, and in fact, many continue to do quite well. Sign up to get it in your inbox every Monday. Continue to STAT+ to read the full story…

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Hospitals Documentation 105

The FDA Law Blog

FEBRUARY 2, 2025

By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. The California Board of Pharmacy updated many of the application forms and guidelines in late 2024.

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Packaging Documentation Compounding 59

PQA

SEPTEMBER 30, 2024

Today, we published the 2024 PQA Annual Report, which documents our progress towards our strategic goals. It is a collection of accomplishments from September 2023 to August 2024 and captures the efforts of our members and staff over the past year. 2024 PQA Leadership Summit, November 7-8 in Arlington, Va.

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Specialty Pharmacies Documentation Communication 52

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co. Internet} US FDA.

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FDA Documentation 98

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?

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Documentation 98

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.

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FDA Documentation Method Validation Packaging 98

PQA

MARCH 12, 2025

Then, in August 2024, PQA released the Advancing Medication Therapy Management Quality Measurement report informed by public comments solicited from PQA members and MTM stakeholders. 1-2 years) Increase standardized HIT for documentation of MTM services Re-establish consensus on standards for clinical documentation for MTM services (e.g.,

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Documentation Patient Care 40

PQA

NOVEMBER 14, 2024

November 7-8, 2024, for the 2024 PQA Leadership Summit. PQA also announced five students who completed the 2024 PQA Healthcare Quality IQ (HQIQ), sponsored by PQA by Innovaccer. PQA members gathered in Arlington, Va., The summit focused on PQA's recent and ongoing work to develop standard pharmacy quality measures.

Specialty Pharmacies 52

Specialty Pharmacies Documentation Patient Care Immunization 52

IDStewardship

DECEMBER 13, 2024

BCPS, BCIDP Article posted 13 December 2024 If you cannot measure it, you cannot determine if you have changedit. In this article an experienced antimicrobial stewardship pharmacist discusses lessons learned from navigating antimicrobial stewardship metrics. Authored by: Timothy P. Gauthier, Pharm.D.,

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Communication Medical Records Documentation 225

IDStewardship

OCTOBER 14, 2024

BCPS, BCIDP Article Posted October 2024, First Released in the June 2024 IDstewardship Newsletter Tip 1: Start by picking an article type and journal The article type (e.g., In this article a pharmacist with experience in writing and publishing provides 5 quick tips for pharmacy residents preparing manuscripts Authored By: Timothy P.

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Documentation Communication 130

pharmaphorum

FEBRUARY 28, 2022

The government previously announced £150 million (around $200 million) to help drive digitisation in social care, and a target of 80% of social care providers to have digital social care records by March 2024.

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Documentation Communication 115

European Pharmaceutical Review

AUGUST 5, 2022

Clinigen Healthcare is recalling three batches of Mexiletine hydrochloride hard capsules, indicated for the treatment of documented arrhythmias, due to a potential risk of under- or overdose, which could have consequences for the safety of patients. First distributed. 84 capsules. 10/02/2022. Batch number. Expiry date. First distributed.

Documentation 98

Documentation 98

Hospital Pharmacy Europe

MAY 17, 2023

from April 2024, and has invited feedback via an online consultation survey. The increases would affect fees for the 2024 registration assessment – for which bookings open in February 2024 – as well as registration renewal fees from April 2024. Fees have been frozen for the last two years in 2022 and 2023.

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Documentation Hospitals 97

The FDA Law Blog

OCTOBER 16, 2023

Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

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Documentation FDA 119

European Pharmaceutical Review

DECEMBER 19, 2023

The document was adopted by EMA’s Management Board at its December meeting. Preparations to support the implementation of the EU AI Act will start in 2024. The plan was prepared by the Big Data Steering Group (BDSG), a joint initiative between HMA and EMA.

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Packaging Documentation 105

The FDA Law Blog

SEPTEMBER 24, 2024

Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. By Deborah L. 89 FR 74966 at 74968 (Sept.

Documentation 59

Documentation FDA Packaging 59

European Pharmaceutical Review

MARCH 19, 2024

percent between 2024-2031. the global continuous bioprocessing market is expected to value $1,067.8 million by 2031. While the market was valued at $255.9 million in 2023, the report predicted it will witness a CAGR of 19.72

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Documentation 94

European Pharmaceutical Review

APRIL 10, 2025

billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment. Annual health-related costs related to PFAS across Europe are estimated at up to 4.6 References CWSRF Emerging Contaminants – Frequent Questions and Answers | US EPA [Internet].

Packaging 59

Packaging Documentation Communication 59

Birth Control Pharmacist

AUGUST 7, 2024

On August 6, 2024, the CDC released the 2024 U.S. MEC) and the 2024 U.S. These documents provide current evidence-based contraception recommendations for health care providers. The 2024 U.S. The 2024 U.S. Get the 2024 Chart Download the updated app including updated recommendations from the 2024 U.S.

Documentation 52

Documentation 52

European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. MHRA announced that it will publish its guidance in 2024.

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Documentation FDA 105

The FDA Law Blog

JUNE 10, 2024

Submit documentation as evidence of addressing the observations (e.g., Document all corrective actions and follow-up to ensure sustained compliance. Comments on the draft guidance can be submitted to the docket by August 5, 2024. Provide a method of verifying or monitoring the effectiveness of the actions.

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FDA Communication Documentation 111

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B.

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FDA Documentation Labelling Communication 105

Hospital Pharmacy Europe

OCTOBER 3, 2024

The crucial role of hospital pharmacists in addressing challenges and improving access to safe, quality medicines and medical devices has been highlighted in a new reference document from the International Pharmaceutical Federation (FIP). This document highlights the importance of access to essential medicines.

Hospitals 52

Hospitals Documentation 52

Blog: Ask a Student Pharmacist

DECEMBER 31, 2024

Frances Abanonu: the power of childhood dreams eomizowh Tue, 12/31/2024 - 12:11 Author: Erin Wilson Third-year PharmD student Frances Abanonu knew at age 11 that she wanted to be a pharmacist. Frances Abanonu Abanonu started a blog to document her experiences as a mom attending school, to both encourage herself and other mothers.

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Documentation Hospitals 52

The FDA Law Blog

MAY 13, 2024

Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. This guidance, when finalized, will replace the original version of this document finalized in 2017. Patients that use ESD undergo continuous 24/7 monitoring.

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FDA Medical Records Documentation 111

The FDA Law Blog

MAY 6, 2024

The guidance does not define “on a reasonably justified regular cycle” or “as soon as possible” but instead recommends manufacturers should “update appropriate cybersecurity documentation (e.g., Appendix 4) for the documentation requirements to “demonstrate reasonable assurance that the device and related systems are cybersecure”.

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FDA Documentation 105

pharmaphorum

NOVEMBER 16, 2022

Instead of checking goods at the border, the protocol allows inspections and document checks to be conducted between Great Britain and Northern Ireland , at Northern Ireland’s ports of entry. “The warning presented by Teva UK is stark,” according to Cameron.

Documentation 105

Documentation 105

The FDA Law Blog

DECEMBER 12, 2024

4, 2024), at 1. The parties have noticed their intentions to offer into evidence documents they identified in their prehearing statements and must serve each other with a copy of the documents noticed in their prehearing statements no later than January 3, 2025. Prehearing Ruling (Dec.

Controlled Substances 52

Controlled Substances Documentation 52

The FDA Law Blog

AUGUST 18, 2024

In effect, these documents serve as road signs helping to direct new market entrants. The agency has done far better in posting 510(k) summaries, which are similar types of documents. The same cannot be said for De Novos from January or February.

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FDA Documentation Hospitals 69