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 Biosimilars Documentation Labelling 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

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 7, 2024

Upon receipt of the 513(g), FDA will assess whether the product meets the definition of a device under section 201(h) of the FD&C Act. Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days.

Documentation 69

Documentation Labelling 69

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

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

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 HIPAA Labelling 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

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

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

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

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

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 68

Immunity Immunization Diabetes Adverse Reactions 68