STAT

DECEMBER 5, 2024

As we approach the end of 2024, First Opinion is publishing a series of essays on the state of AI in medicine and biopharma.

Documentation 271

Documentation 271

Safe Biologics

FEBRUARY 1, 2024

Comments may be submitted here until April 30, 2024. UPCOMING EVENTS WHO 78th INN Consultation Geneva, Switzerland – March 19, 2024 ASCO Annual Meeting Chicago, IL – May 31-June 4, 2024 BIO International Meeting San Diego, CA – June 3-6, 2024 DIA Global Annual Meeting San Diego, CA – June 16-20, 2024

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

Drug Channels

NOVEMBER 15, 2023

In Medicare Part D in 2024: The Seven Largest Companies' Preferred Pharmacy Networks and the Coming Collapse of the PDP Market , I documented how those networks now dominate stand-alone Medicare Part D prescription drug plans (PDPs) and have become a major presence in Medicare Advantage prescription drug (MA-PD) plans. to 1:30 p.m.

Documentation 90

Documentation 90

Safe Biologics

MAY 21, 2024

UPCOMING EVENTS ASCO Annual Meeting Chicago, IL – May 31-June 4, 2024 BIO International Meeting San Diego, CA – June 3-6, 2024 DIA Global Annual Meeting San Diego, CA – June 16-20, 2024 ACR Convergence 2024 Washington, DC – November 14-19, 2024 Read the concept paper here. Read it here.

Biosimilars 100

Biosimilars Documentation 100

Express Pharma

JUNE 28, 2024

Indian Pharmaceutical Alliance (IPA) concluded the 9th edition of the Global Pharmaceutical Quality Summit 2024. The day concluded with insights into future data and documentation imperatives, highlighting meticulous record-keeping and data management for compliance and quality.

Biosimilars 108

Biosimilars Documentation 108

Express Pharma

OCTOBER 6, 2024

The AL Ideathon 2024, hosted on 28th September at Novotel, Hyderabad, showcased the intersection of pharmaceuticals, technology, and research and development. Anurag Gokhale’s submission, focused on voice search-enabled systems for documentation efficiency, received the Golden Innovation Award.

Documentation 105

Documentation 105

Pharmaceutical Technology

MARCH 28, 2024

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

Documentation 113

Documentation Vaccines 113

FDA Law Blog: Biosimilars

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.

Documentation 59

Documentation Communication 59

Express Pharma

JUNE 6, 2024

Stakeholders are invited to provide feedback on CDSCO draft guidance within 15 days from the notice’s issuance On May 29, 2024 a draft of the revised “Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines” was released for public consultation by Central Drug Standard Control Organisation (CDSCO).

Vaccines 105

Vaccines Documentation 105

Safe Biologics

FEBRUARY 1, 2024

Comments may be submitted here until April 30, 2024. When the biosimilar demonstrates a high degree of similarity to the RMP at the analytical and functional level, it may be possible to justify the omission of dedicated CES. Read the concept paper here.

Biosimilars 100

Biosimilars Documentation 100

Putting Patients First Blog

JANUARY 11, 2024

New NHC Project Looking at Chronic Kidney Disease Disparities January 11, 2024 By: Lillian Q. it is estimated that about 37 million adults live with chronic kidney disease (CKD). 1 Once diagnosed, the complexity of management and treatment of CKD can severely impact lifestyle of patients and have dire implications for family members.

Mayo Clinic 111

Mayo Clinic Documentation 111

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

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.

Documentation 98

Documentation Pharmaceutical Manufacturing 98

Express Pharma

DECEMBER 5, 2023

Under the agreement, Cyprium completed the transfer of its worldwide proprietary rights and US FDA documents pertaining to CUTX-101, the copper histidinate product candidate for the treatment of Menkes disease, to Sentynl. A rolling submission of the CUTX-101 New Drug Application (NDA) to the FDA is ongoing, with expected completion in 2024.

Documentation 103

Documentation 103

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

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

Drug Channels

MAY 14, 2024

As we document below, a growing share of Part B drugs have inflation-adjusted coinsurance rates that have been increasing , not declining. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. Chalk off these coinsurance surprises to yet another unintended consequence of the IRA.

Documentation 86

Documentation 86

Express Pharma

JUNE 12, 2024

The Indian Pharmaceutical Alliance (IPA) is set to host the ninth edition of the Global Pharmaceutical Quality Summit, on June 27 and 28, 2024 in Mumbai. The participants can gain deeper insights on recent focus areas such as Quality Management Maturity Models, Data and Documentation Imperative and Talent Capability Building.

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing Documentation 105

Express Pharma

AUGUST 16, 2024

FOPE and Pharma State Academy recently hosted, third session of their PULSE series on August 11, 2024, spotlighting “Quality Risk Management (QRM)” with a special focus on the Revised Schedule M. The panel also discussed the differences between ICH Q9 and the Revised Schedule M, and the importance of meticulous documentation.

Documentation 111

Documentation Communication 111

Putting Patients First Blog

APRIL 29, 2024

Recognizing both the potential benefits and challenges of the MPPP rollout, the NHC views the introduction of these documents as crucial for educating beneficiaries on their options, easing transitions, and possibly lessening the financial impact of prescription costs.

Documentation 40

Documentation Insurance Coverage and Processing Communication Pharmacy Technician 40

Drug Channels

NOVEMBER 19, 2024

In Medicare Part D in 2025: Preferred Pharmacy Networks Fade in a Collapsing PDP Market , I documented the Inflation Reduction Act’s (IRA) disruption to Medicare Part D prescription drug plans (PDPs). As always, we provide you with a handy table for tallying each chain’s participation and changes from 2024 to 2025. Fein, Ph.D.,

Documentation 76

Documentation 76

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

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.

Documentation 115

Documentation Communication 115

FDA Law Blog: Biosimilars

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.

Documentation 119

Documentation 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.

Packaging 105

Packaging Documentation 105

The Happy PharmD

SEPTEMBER 15, 2024

The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue. The post State of Well-Being 2023-2024 appeared first on The Happy PharmD. A survey conducted in 2021 highlighted this concern, indicating that workforce issues are a common challenge.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Dosage Documentation Communication 52

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

Documentation 94

Documentation 94

Big Molecule Watch

AUGUST 20, 2024

On July 25, 2024, the FDA published a notice establishing a public docket for commenting to obtain information to assist the FDA in assessing how best to advance the development of new biosimilar products, as part of the Biosimilar Use Free Amendments of 2022 (“BsUFA III”).

Biosimilars 45

Biosimilars Documentation 45

Drug Channels

APRIL 2, 2024

of our new 2024 Economic Report on U.S. Below you'll find details and links to source documents. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. For more on acquisition cost reimbursement for pharmacies, see Sections 8.4. and 12.3.4. Pharmacies and Pharmacy Benefit Managers.

Documentation 65

Documentation 65

FDA Law Blog: Biosimilars

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 Packaging 59

Proxsys Rx

APRIL 19, 2024

And that is why the one 340B prediction we can make for 2024, unequivocally, is repeated three times in this post’s headline. Which means we may see a lot more states putting manufacturers in their place, in 2024. How covered entities should prepare for 340B changes in 2024 Build a qualified 340B team. And More Change.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Drug Pricing Packaging 52

Safe Biologics

OCTOBER 13, 2024

Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies for Interchangeable Biosimilars; Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars FOR IMMEDIATE RELEASE – September 4, 2024 Arlington, VA- U.S. physicians. physicians.

Biosimilars 100

Biosimilars Documentation 100

Pharma Leaders

APRIL 7, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

Documentation 52

Documentation 52

Express Pharma

MARCH 12, 2024

300 crore, over the next two fiscal years (150 units each in 2024-25 and 2025-26). We appeal to the Government to ensure NIPER imparts training for documentation because machines alone cannot cause compliance of Schedule M. Documentation is an altogether different skill without which compliance is not possible.

Documentation 105

Documentation Pharmaceutical Manufacturing 105

Drug Channels

OCTOBER 3, 2024

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. For the fourther quarter of 2024, coinsurance rates for 51 drugs increased, while rates for only 19 drugs decreased. All rights reserved.

Documentation 52

Documentation 52

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

Drug Channels

JUNE 18, 2024

Click here to see the original post from April 2024. Last week, we documented the substantial concentration of dispensing revenues for specialty drugs. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. All rights reserved. This Feed is for personal non-commercial use only.

Specialty Pharmacies 52

Specialty Pharmacies Drug Pricing Documentation 52