Pharmaceutical Technology

APRIL 17, 2023

Also known as brexpiprazole, the FDA first approved Rexulti as a treatment for adults with schizophrenia and as an add-on treatment for adults with major depressive disorder in July 2015. He added that there is also a need for FDA-approved products that communicate efficacy and safety on their labels.

Medical Schools 96

Medical Schools Labelling Communication 96

ALiEM - Pharm Pearls

MARCH 7, 2024

Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. 2015 [14] Case series in a pediatric ED, over a 2-year period N=8 5-17 years 8 cases of nephrolithiasis were identified with POCUS in patients presenting with renal colic.

Labelling 177

Labelling Communication 177

European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively.

Labelling 111

Labelling 111

pharmaphorum

DECEMBER 15, 2022

Ofev (nintedanib) has been recommended since 2015 for NHS use in IPF patients who have a forced vital capacity (FVC) value of 50% to 80% of normal, but will now be an option for people with less severe disease, i.e. an FVC of more than 80%.

Labelling 105

Labelling Hospitals 105

European Pharmaceutical Review

AUGUST 23, 2022

However, the researchers noted that a larger number of warning letters were issued to pharmaceutical manufacturers (ie, by CDER) than to medical device manufacturers (by CDRH) between 2015 and 2020. The major reasons for this were poor cGMP compliance and misbranding.

Documentation 105

Documentation Pharmaceutical Manufacturing Packaging Labelling 105

pharmaphorum

SEPTEMBER 15, 2021

It is thought that around five million women in the US have uterine fibroids that cause symptoms, with two-thirds of them inadequately treated with current drugs – generally off-label oral contraceptives or injectable GnRH agonists like leuprolide acetate or goserelin acetate. Linzagolix is not currently approved anywhere in the world.

Labelling 98

Labelling 98

RX Note

NOVEMBER 4, 2023

The remedies may provide a placebo benefit or may be labelled as homeopathic but actually contain measurable concentrations of drugs, nutrients or dietary supplements. The letters M and CM are used to represent greater dilution levels of 1000 and 10000.

Labelling 52

Labelling Community Pharmacies 52

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

Labelling 59

Labelling Packaging Documentation 59

Safe Biologics

NOVEMBER 12, 2023

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. Read more about the approval here.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

pharmaphorum

FEBRUARY 9, 2022

According to a report by IQVIA last year, there were 3,500 oncology-focused therapeutic candidates in the pipeline, which represents a 75% increase on figures seen in 2015. Closely related to this is the fact that global spending on oncology drugs reached $164 billion in 2020, with drug sales growing at a compound annual growth rate of 14.3%

Vaccines 134

Vaccines Immunity Immunization Labelling 134

Pharma Marketing Network

MARCH 25, 2022

Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. 2015-2017 Behavioral Risk Factor Surveillance System (BRFSS) Data from adults in 44 States, Puerto Rico, and the District of Columbia. Connect at linkedin.com/in/sunnywhite/ . REFERENCES: Gilda’s Club.

Labelling 98

Labelling Drug Development 98

RX Note

JUNE 9, 2023

FDA Pregnancy and Lactation Labelling Final Rule, 2015 In the past, FDA Pregnancy Categories was used in US. To address this, on 13 December 2014, the FDA published the Pregnancy and Lactation Labelling Rule” (PLLR). Labelling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

Labelling 52

Labelling Adverse Reactions 52

FDA Law Blog: Biosimilars

AUGUST 11, 2024

The approved labeling for AUVI-Q includes warnings and precautions regarding emergency treatment, injection-related complications, serious infections at the injection site, allergic reactions associated with sulfite, and disease interactions. The Mirati letter deals with much more nuanced issues than the letter to kaleo.

Labelling 59

Labelling Communication 59

pharmaphorum

MARCH 11, 2022

Vraylar, sold in some markets as Reagila, was first approved in 2015 for schizophrenia and bipolar disorder, with its label extended in 2017 to include maintenance treatment of schizophrenia and again in 2019 for bipolar depression.

Clinical Pharmacology 52

Clinical Pharmacology Labelling 52

pharmaphorum

AUGUST 9, 2022

Tagrisso meanwhile has been FDA-approved as a second-line treatment for EGFR T790M mutation-positive NSCLC since 2015, with its label extended since then to include first-line and adjuvant treatment. It is AZ’s biggest-selling drug, with sales topping $5 billion last year.

Chemotherapy 52

Chemotherapy Labelling 52

RX Note

JUNE 8, 2023

In the past, package inserts were not always reliable sources of information regarding medication safety during lactation.

Labelling 40

Labelling Packaging 40

pharmaphorum

OCTOBER 30, 2022

The two groups were also separated by a sizeable time difference, with data from the control group ranging between 1990 and 2015, while Study 03-133 started enrolling patients in 2004. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

Documentation 52

Documentation Labelling Immunity Immunization 52

RX Note

OCTOBER 5, 2023

Such events may be related to professional practice and healthcare products, procedures and systems, including prescribing; order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Compounding 52

RX Note

OCTOBER 5, 2023

Meanwhile, an unnecessary health risk is created in the home whereby the patient or family members may accidentally consume expired medicines or wrong drug (due to unclear or damaged labels). Failure to discard medications properly may also contaminate the environment through poor disposal either via trash or sewer system.

Medication Dispensing 40

Medication Dispensing Community Pharmacies Hospitals Labelling 40

Quality Matters

JUNE 26, 2023

Ensuring quality is essential Regulatory agencies and pharmacopeias around the world establish guidelines and requirements for generics manufacturers to follow in the manufacturing, testing, and labeling of their drug products to ensure they meet the same quality standards as the innovator product. Food and Drug Administration. MAPP 5240.10.

Dosage 52

Dosage Generic Medicine Labelling 52

RX Note

MARCH 23, 2023

Product should be labelled clearly and stored as recommended within the formula. Vehicle in Extemporaneous Formulation Flipping through Extemporaneous Formulation, 2015 , you may come across a total of 4 common vehicles, namely: Simple Syrup Is a sucrose solution , which has a sweet taste.

Compounding 52

Compounding Health and Personal Care Stores Hospitals Dosage 52

RX Note

APRIL 3, 2024

External Links American Academy of Ophthalmology - Glaucoma MSD Manual Professional - Glaucoma Meta-analysis of the efficacy and safety of alpha2-adrenergic agonists, beta-adrenergic antagonists, and topical carbonic anhydrase inhibitors with prostaglandin analogs, 2010 Twelve-month, randomized, controlled trial of bimatoprost 0.01%, 0.0125%, and 0.03% (..)

Dosage 52

Dosage Labelling Diabetes 52

Quality Matters

MARCH 1, 2024

Nature 520, 609–611 (2015). PGx presents opportunities for USP to collaborate with key stakeholders who are already developing PGx standards and guidelines and to apply its standards-setting process to establish alignment and consistency in PGx standards. Personalized Medicine Coalition. ii Personalized Medicine 101. iii Schork, N.

Labelling 52

Labelling Compounding 52

Pharmaceutical Technology

JANUARY 6, 2023

In Par and Novartis’ agreement, Par gained exclusive rights to market its generic for six months after Novartis’ period of exclusivity finished, beginning September 30, 2014 and ending March 30, 2015. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

The Thyroid Pharmacist

OCTOBER 7, 2022

Sure enough, she read all the labels on her supplements and in her pantry, and gave her kitchen a stevia-free makeover. I encourage you to read the labels and look for 100% pure, USDA-approved stevia products where possible. May 21, 2015. Published 2015 Apr 2. What Are the Benefits of Stevia? What About Other Sweeteners?

Diabetes 98

Diabetes Immunity Immunization Labelling 98

The Thyroid Pharmacist

DECEMBER 28, 2022

Then in 2015, I realized that we, the thyroid community, have the power to conduct our own research! In this article (which was originally published in 2015), we’ll dive into the results of the survey and discuss some important considerations for those with Hashimoto’s, including: How stress contributes to Hashimoto’s.

Immunity 111

Immunity Immunization Clinical Pharmacology Doctor of Pharmacy 111

The Thyroid Pharmacist

AUGUST 23, 2023

Plus, 36 percent of my readers whom I surveyed in 2015 , said that thiamine helped them feel better… so a daily thiamine supplement may just be the key to recovering your old self! Thiamine and fatigue in inflammatory bowel diseases: an open-label pilot study. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. doi: 10.1089/acm.2011.0840.

Dosage 98

Dosage Labelling 98

The Thyroid Pharmacist

NOVEMBER 10, 2023

These holes allow for food molecules, such as gluten, to pass through, and the body labels these molecules as foreign invaders. Published 2015 Feb 27. Published 2015 Jul 30. Note: Originally published in February 2015, this article has been revised and updated for accuracy and thoroughness. 2015;7(3):1565-1576.

Immunity 105

Immunity Immunization Labelling 105

RX Note

JUNE 5, 2023

A simple method is to use a small adhesive label to mark the position and thus produce a measure with just one graduation.) Furthermore, in late August 2020, the FDA approved labelling changes for hydrochlorothiazide (HCTZ) to inform clinicians and patients about the slight risk of developing non-melanoma skin cancer.

Compounding 52

Compounding Labelling Packaging Hospitals 52

RX Note

APRIL 11, 2023

2015 Avoiding the "triple whammy" in primary care, 2018 Off-Label Use of Diclofenac Suppositories to Treat Fever in Children: Potential Risk of Acute Necrotising Encephalopathy of Childhood (ANEC), 2023

Labelling 40

Labelling 40

pharmaphorum

AUGUST 25, 2021

In 2015, PEPFAR reached out to Gilead and said they were working with the government in Sub-Saharan Africa. If you get past the regulatory hurdles, then you have to look at labelling requirements, packaging requirements, and quality assurance requirements.”.

Packaging 52

Packaging Labelling Compounding 52

National Association of Boards of Pharmacy

AUGUST 29, 2022

However, since 2015 , the types of medical products sold illegally online have grown. In Costa Rica, pre-filled syringes labeled “Tuberculin” were among the 11,187 units of unregistered, fake, and expired medicines seized at the border.

Online Pharmacies 40

Online Pharmacies Labelling 40

The Thyroid Pharmacist

JUNE 30, 2023

In 2015, I conducted a survey of over 2000 readers with Hashimoto’s , asking for the most helpful interventions in their health journeys. Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. Have you heard of low dose naltrexone, or LDN? LDN is truly an intriguing drug.

Compounding 98

Compounding Immunity Immunization Compounding Pharmacies 98

The Thyroid Pharmacist

SEPTEMBER 6, 2023

Personal Care : The Wellnesse line of haircare and toothpastes by Katie Wells (aka the “Wellness Mama”) contains high-quality, safe ingredients that are clearly labeled, so there are no surprises! 27 April 2015. (My readers can use code IZABELLAWENTZ for 15% off all Starter Kits.) Endocrine Research. 2015;40(4):204-210. Lupkin, Sydney.

Health and Personal Care Stores 91

Health and Personal Care Stores Packaging Labelling Compounding 91

Putting Patients First Blog

DECEMBER 5, 2024

FDA-2015-D-1580] Submitted electronically via regulations.gov Dear Commissioner Califf, The National Health Council (NHC) appreciates the opportunity to provide comments on the FDA’s draft guidance Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle. 10 (2015): 298493.

Labelling 40

Labelling Communication Mayo Clinic 40

The Thyroid Pharmacist

AUGUST 18, 2023

11] In a 2015 study on residents in the Pak Pattan District of Pakistan, a population with a high frequency of goiter, researchers reported that turmeric use was associated with reduced goitrogenesis (goiter formation) Nutr Res. Note: Originally published in July 2015, this article has been revised and updated for accuracy and thoroughness.

Dosage 98

Dosage Compounding Labelling Diabetes 98

The Thyroid Pharmacist

JUNE 28, 2023

Wellnesse – This line of personal care products by Katie Wells (the “Wellness Mama”) contains high quality, safe ingredients that are clearly labeled, so there are no surprises! 2015 Aug;67(4):321-5. This offer is only good through July 31st, so order yours now! Endocrine Connections. 2017;6(8):647-658. doi:10.1530/EC-17-0243.

Labelling 88

Labelling 88