Pharma in Brief

JANUARY 10, 2024

We also flag what to watch out for in 2024. Expected highlights for 2024 include a final PTA regime, more details on PMPRB drug pricing guidelines and national pharmacare, and fall-out from the US mass drug importation program targeting Canadian medicines. Draft regulations are expected to be released for consultation in 2024.

Drug Pricing 52

Drug Pricing Documentation Biosimilars Vaccines 52

STAT

FEBRUARY 28, 2024

antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022 , STAT writes. The … A much-anticipated inquiry by U.S.

Documentation 279

Documentation 279

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

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 90

Documentation Pharmaceutical Manufacturing 90

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

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

Big Molecule Watch

MAY 3, 2024

The guidance remains in draft form and, as with any FDA guidance document, it is not legally binding and, when final, will reflect FDA’s “current thinking” on this topic. The 60-day comment period for this revised draft guidance ends on 6/24/2024. Instructions for submitting comments to this guidance can be found here.

Biosimilars 62

Biosimilars Communication Labelling Documentation 62

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 63

Documentation 63

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 93

Documentation Pharmaceutical Manufacturing 93

Putting Patients First Blog

JANUARY 22, 2024

January 22, 2024 By: Annlouise Assaf – Sr. There are customizable health literacy checks content developers can include when reviewing their documents. Users simply upload their document directly into the Clear-AI digital platform and receive suggested feedback and readability scores on their respective content.

Documentation 40

Documentation Communication Hospitals 40

FDA Law Blog: Biosimilars

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”.

Documentation 103

Documentation 103

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 69

Documentation 69

FDA Law Blog: Biosimilars

AUGUST 7, 2023

Submit proposal documents by email to ELP Proposal Submissions by September 5, 2023 at 12 PM ET. Complete a Site Visit Agenda ( Sample Site Visit Agenda ). Identify the site visit duration. Most common are one- or two-day site visits.) Indicate ability to host a virtual site visit.

Documentation 40

Documentation 40

Drug Channels

DECEMBER 6, 2023

Below you'll find details and links to source documents. For more on the future of PBM and pharmacy pricing, join me on December 15 for a new live video webinar: Drug Channels Outlook 2024. Is the world ready for new ways to price pharmacy and pharmacy benefit manager (PBM) services? Click here to learn more and sign up.

Documentation 67

Documentation 67

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 91

Packaging Documentation 91

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

Putting Patients First Blog

FEBRUARY 5, 2024

A Reminder of NHC Benefits February 5, 2024 By: Bob Scott, Director, Member Services The National Health Council (NHC) brings diverse organizations together to forge consensus, drive patient-centered health policy, and provide a united voice for the more than 160 million people with chronic diseases and disabilities and their family caregivers.

Documentation 59

Documentation Communication 59

Big Molecule Watch

JANUARY 5, 2024

Regeneron seeks a PI schedule to “ensure an orderly process that will result in resolution of its forthcoming motion for PI before May 17, 2024,” when its regulatory exclusivity period ends. The proposed schedule also provides dates for document discovery and depositions.

Packaging 62

Packaging Biosimilars Documentation 62

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

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 88

Documentation 88

Pharma in Brief

NOVEMBER 12, 2023

The Board previously indicated that a second phase of consultation in 2024 would focus on the development of new Guidelines. The scoping paper states that the Board intends to finalize new Guidelines in 2024. The Board indicated that a “What We Heard” document will be released in 2024.

Drug Pricing 52

Drug Pricing Documentation 52

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 114

Documentation Communication 114

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.

Documentation 91

Documentation 91

FDA Law Blog: Biosimilars

JUNE 20, 2023

The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry. Draft Guidance Finally, as part of MDUFA V , FDA has committed to issuing an updated draft of this Q-Sub guidance, by March 31, 2024.

Documentation 45

Documentation Communication 45

Putting Patients First Blog

NOVEMBER 16, 2023

The dossier model and disease-specific dossiers would be living documents updated over time, with patient organizations being the lead owners of these data. Current exploration of PED dossier demonstration projects is underway for 2024. A PED dossier template would describe a consistent format (e.g., expected headers and content).

Documentation 52

Documentation 52

FDA Law Blog: Biosimilars

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.

Documentation 105

Documentation Labelling Communication 105

pharmaphorum

FEBRUARY 9, 2022

The main bullet points in the plan include an objective of eliminating any delays to procedures of 18 months or more by April 2023 and over 65 weeks by March 2024, and reducing all waits to less than a year by 2025 – a year after the next scheduled general election. end waits over a year for 99% of people by 2024, and everyone by 2025.

Hospitals 52

Hospitals Documentation 52

European Pharmaceutical Review

JANUARY 13, 2023

and implemented from January 2024. Approval of the Guide on the declassification of documents pertaining to the work of the Ph. Recent feedback from Heads of Medicines Agency (HMA), and European Medicines Agency (EMA), groups and from the national competent authorities of non-EU Ph. Member States. Supplement 11.3 The post Ph.

Documentation 94

Documentation Vaccines 94

Board Vitals - Pharmacist

DECEMBER 1, 2023

With 2024 rapidly approaching, there comes the question of New Year’s Resolutions. To simplify our EHR and make documentation easier and quicker. I hope to work with different EHRs to find one where surgeons can put the focus back on the patient and allow the surgeon to quickly and completely document the encounter.

Communication 98

Communication Documentation Diabetes 98

Birth Control Pharmacist

FEBRUARY 12, 2024

Pharmacists must be familiar with billing codes, insurance coverage policies, and documentation requirements to facilitate seamless transactions and ensure fair compensation for their services. Candidate, is a 4th-year student pharmacist in the Class of 2024 at Shenandoah University Bernard J. About the Author Rebecca Exantus , Pharm.D

Documentation 52

Documentation 52

pharmaphorum

MARCH 8, 2022

The company didn’t conduct a conference call to discuss the findings, but took the unusual step of publishing a frequency asked questions (FAQ) document on the study, headlined with a non-committal statement about whether the data were “clinically meaningful.”

Chemotherapy 52

Chemotherapy Documentation Labelling 52

pharmaphorum

JUNE 10, 2022

The FDA reviewer said in briefing documents published ahead of the advisory committee meeting that there had been cases of myelodysplastic syndrome (MDS), a form of cancer, in around 4% of children treated with eli-cel, leading to speculation that the panel may have taken a more guarded stance on the therapy.

Documentation 98

Documentation Immunity Immunization 98

Pulses

SEPTEMBER 26, 2023

A retrospective analysis of PharmCas applications was conducted for the admitted Class of 2024 at The University of Texas College of Pharmacy. This review aimed to examine the implementation of clinical case-based OSCEs, which were initiated in the program during the class of 2024’s second year of pharmacy school.

Communication 59

Communication Hospitals Documentation 59

pharmaphorum

AUGUST 11, 2022

The score measures rates of nutrition screening, assessment by a registered dietitian nutritionist, malnutrition diagnosis by a physician, and nutrition care plan documentation. What is the Global Malnutrition Composite Score?

Hospitals 52

Hospitals Inpatient Documentation 52

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

Pharma in Brief

FEBRUARY 13, 2024

Link to decision Novartis AG v Biogen Inc , 2024 FC 52 The FC heard evidence that concerns had been raised about confusion by the European Medicines Agency and Health Canada. However, the FC noted that the Respondents had not sought or established the need for a stay of injunctive relief in light of these requirements.

Biosimilars 59

Biosimilars Documentation 59

GMPSOP

MARCH 30, 2024

Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch. Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error. .

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52