European Pharmaceutical Review

DECEMBER 20, 2023

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents.

Biosimilars 98

Biosimilars Labelling Documentation 98

GMPSOP

JUNE 28, 2024

Additional documents included each month. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. Additional documents included each month. Additional documents included each month. Checkout sample preview s.

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. It begs the question of why only two botanical drug products have obtained FDA approval and fulfilled the Botanical Guidance definition of a botanical product.

Drug Development 103

Drug Development Documentation Biosimilars Compounding 103

GMPSOP

AUGUST 23, 2022

Assessing the impact of changes to a process/system The use of quality risk management and the methodology to be used should be documented in the relevant validation plan or change management procedure. Additional documents included each month. process change, product recall, labelling change, adverse event/safety reporting)?

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

GMPSOP

NOVEMBER 6, 2022

These standards can only be used if they are standardized against primary standards using definitive methods that are published in pharmacopoeias, and national and international standards. Additional documents included each month. d) When the reference standard is first opened, an “opened date” must be written on the label of the vial.

Labelling 52

Labelling Documentation Packaging Communication 52

RX Note

DECEMBER 17, 2023

SODA - Sale of Drugs Act 1952 CDCR - Control of Drugs and Cosmetics Regulations 1984 DCA - Drug Control Authority Key Definitions "Drug" includes any substance, product or article intended to be used or capable, or purported or claimed to be capable, of being used on humans or any animal, whether internally or externally, for a medicinal purpose.

Documentation 40

Documentation Labelling 40

RX Note

JUNE 4, 2023

Introduction Once, I received a query from a ward nurse: If a product label mentioned that "Do not store over 25°C", is it fine for us to keep the medication in fridge? What does a cool place on the product label mean? Read the label to know the recommended storage temperature range.

Drug Storage 52

Drug Storage Labelling Medication Labelling Documentation 52

GMPSOP

MARCH 17, 2023

By definition, corrective actions are required to eliminate the causes of an existing nonconformity, defect, or other undesirable situation. Additional documents included each month. Additional documents included each month. Corrective actions are taken to fix a defect on hand. All written and updated by GMP experts.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

Putting Patients First Blog

APRIL 7, 2025

12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier. Finally, to support transparency, reproducibility, and traceability, the FDA should require thorough documentation of AI model validation and verification.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

FDA Law Blog: Biosimilars

MAY 19, 2023

Serial testing was defined as testing symptomatic individuals twice over three days with at least 48 hours between tests, which is in accordance with study findings from the National Institute of Health referenced here and current EUA labeling for serial testing. Customer Support Help line).

Labelling 40

Labelling Documentation 40

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

In 1997, the Food and Drug Administration Modernization Act (FDAMA) amended the definition to make clear that substantial evidence could also be demonstrated by “one adequate and well-controlled clinical investigation and confirmatory evidence.” However, the Act does not define what may constitute such confirmatory evidence.

Drug Development 64

Drug Development Documentation Labelling Medical Records 64

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

Packaging 59

Packaging Documentation Labelling Communication 59

GMPSOP

MARCH 4, 2023

Additional documents included each month. Quality management system is primarily involved in ensuring good manufacturing practice (cGMP), good laboratory practice (GLP), good documentation practice (GDP), good automated manufacturing practice (GAMP) etc. The quality risk management framework is ingrained in its definition.

Documentation 52

Documentation Communication Method Validation Packaging 52

Putting Patients First Blog

JULY 2, 2024

The NHC requests more clarity on how CMS will exclude QALY-based metrics and highlight when they have been removed from consideration in MFP justification documentation. Without appropriate guardrails, CMS’ broad definition of drugs eligible for negotiation may discourage these types of improvements. hstc=117268889.c6acac5669d4f1e6063a774e6d96c6b5.1716560813145.1716560813145.1716560813145.1&

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

Viseven

NOVEMBER 17, 2022

Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug. They provide information about the following: Off-label usage Publications Safety information Independent medical education. What do medical affairs teams do? .

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Putting Patients First Blog

AUGUST 21, 2023

For example, CMS has implemented CED for novel amyloid beta-targeting therapies for Alzheimer’s disease even when these therapies are being used according to their FDA- approved label and accepted medical practice, and continued CED even once products have transitioned from accelerated approval to traditional approval.

Documentation 40

Documentation Labelling 40

GMPSOP

APRIL 3, 2024

A pharmaceutical warehouse is responsible for receiving, storing, and releasing incoming goods (including labeling and packaging) and distributing finished products. Therefore, GMP rules ensure that materials are handled and stored properly and that appropriate documentation is maintained. Additional documents included each month.

Labelling 52

Labelling Packaging Documentation Inventory Control 52

The Happy PharmD

OCTOBER 26, 2022

These documents focused on why the sentinel event occurred. Both the label and the product had to match the order before the product. No, but something was definitely wrong when I was checking the IV solutions.”. We found nothing wrong with the IV solutions or their labeling. Blaming Employees For Sentinel Events.

Hospitals 52

Hospitals Pharmacy Technician Labelling Medical Records 52

RX Note

JUNE 3, 2023

What are the legal requirements of labelling on a medication for a dispensed medicine by pharmacist? What is the definition of Zero and first order reaction Bioavailability Elimination rate constant Half-life Steady-state Given a drug has volume distribution of 0.2 How long should a fully dispensed prescription be kept for?

Health and Personal Care Stores 40

Health and Personal Care Stores Chemotherapy Compounding Dosage 40

FDA Law Blog: Biosimilars

JANUARY 20, 2025

Gaulkin & Ritte van Laack Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here , here , and here ). For foods that do not have established definitions and standards of identity (i.e., The description or name of the food (i.e.,

Labelling 52

Labelling Documentation Packaging 52

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night.

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

Dosage 98

Dosage Documentation Diabetes Labelling 98

FDA Law Blog: Biosimilars

JANUARY 2, 2025

The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients. Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat.

Labelling 52

Labelling Documentation 52

Ramblings of a pharmacist

OCTOBER 26, 2022

To all external observers, the medication looked legitimate – it bore a normal label, it was the right size, the product tracing documentation was received in good order. Biktarvy® and other HIV drugs are generally labeled to “dispense in original packaging” so the pharmacist never broke the seal on the bottle.

Documentation 40

Documentation Labelling Independent Pharmacies Community Pharmacies 40

FDA Law Blog: Biosimilars

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B

Documentation 95

Documentation Labelling Communication 95

The Thyroid Pharmacist

NOVEMBER 8, 2024

Fermented foods are also great, and are definitely one of my 12 favorite beneficial healing foods for the gut. As such, I re-analyzed the data for the “presence” of parasite DNA labels, and the incidence was substantially higher… 274 total parasites were detected! (See my article on probiotics for more information on this.)

Immunity 80

Immunity Immunization Diabetes Adverse Reactions 80

FDA Law Blog: Biosimilars

MAY 26, 2025

The gray box at the top of the document at this link shows the change in position. Were not trying to bury the lead here, but the battle of labeling these surgical and drug treatments is a political one. Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care.

Labelling 59

Labelling HIPAA Documentation Immunity 59