pharmaphorum

JULY 7, 2025

With its new filing, J&J seems to have set aside concerns about activity in non-BRCA patients, submitting Akeega for approval with a broad HRR-positive label claim. Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved. pharmaphorum – an EVERSANA company

Diabetes

EMCrit Project

JULY 23, 2025

Subscribe Login Notify of new follow-up comments new replies to my comments Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* intensivist, CCRN, etc.) Δ Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* Your Job (i.e. Your Job (i.e.

Labelling

EMCrit Project

JULY 19, 2025

Subscribe Login Notify of new follow-up comments new replies to my comments Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* intensivist, CCRN, etc.) Δ Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* Your Job (i.e. Your Job (i.e.

Labelling

EMCrit Project

JUNE 16, 2025

intensivist, CCRN, etc.) Δ Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* All EMCrit Content is a product of EMCrit LLC; Copyright 2009-. All PulmCrit and IBCC Content are a product of Farkas Medical LLC; Copyright 2009-. Your Job (i.e. Your Job (i.e.

Labelling

pharmaphorum

JUNE 30, 2025

Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved. Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved. pharmaphorum – an EVERSANA company The rights of trademark owners are acknowledged.

Vaccines

EMCrit Project

JUNE 12, 2025

Subscribe Login Notify of new follow-up comments new replies to my comments Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* intensivist, CCRN, etc.) Δ Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* Your Job (i.e. Your Job (i.e.

Labelling

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP).

Labelling

LifeProNow

MARCH 17, 2023

The MRTP process outlined in the 2009 Family Smoking Prevention and Tobacco Control Act allows companies to submit applications for the FDA to evaluate whether a tobacco product may be sold or distributed for use to reduce harm or the risk of tobacco-related disease.

Labelling

Pharmaceutical Technology

JULY 29, 2022

Off-label medication options. Abilify (aripiprazole) , marketed by Bristol Myers Squibb and Otsuka Pharmaceuticals, was approved in 2009 for irritability treatment in six to 17-year-old children with ASD. An inability to clearly communicate with others and express their wants and needs results in frustration, he adds.

Communication

pharmaphorum

MARCH 3, 2021

Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009. In September last year Mylan and Kindeva argued in the trial that each asserted patent claim is invalid under US patent laws.

Labelling

European Pharmaceutical Review

DECEMBER 20, 2023

Draft Report on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC. analysis (Source: L.E.K) Internet] 2023. cited 2023Dec] Available from: [link] European Parliament.

Biosimilars

Eye on FDA

JANUARY 9, 2022

Back in 2009 you may recall that FDA issued 45 Untitled Letters aimed at 14 companies regarding the use of banner ads/sponsored links where clearly benefits of a branded product were available, but risk information only ascertainable by clicking on a link. in November 2009. The Substance: What triggered the enforcement actions?

Communication

Syner-G

AUGUST 9, 2022

IMPACT (now part of Syner-G BioPharma Group) has been providing Regulatory Affairs support to a mid-size pharmaceutical company since 2009. Regulatory Affairs Strategy and Project Team Lead. Even though this company has a Regulatory Affairs Department, their rapid growth over the years has made “in-sourcing” of help a necessity.

Labelling

RX Note

JUNE 12, 2025

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

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

Pharmaceutical Technology

MAY 11, 2008

For example, Turkey will require track and trace by 1 January 2009 and California is requiring the technology by 1 January 2011. Consequently, the implementation of track and trace systems for pharmaceuticals is becoming more important as countries make it a legal requirement.

Packaging

Pharmaceutical Technology

JANUARY 6, 2023

As per the US Department of Justice release, Novartis Greece admitted making improper payments to Greek healthcare providers between 2009 and 2010, for an epidemiological study that was intended to increase sales of Novartis prescription drugs. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.

Documentation

Eye on FDA

JULY 7, 2020

The drug in question is Schedule II drug and bears a Boxed Warning on its label, yet the link contained no risk information about the drug, despite the fact that there was present information about the benefits of the drug, according to OPDP’s letter.

Communication

Putting Patients First Blog

JULY 10, 2023

Another key aspect to supporting the successful implementation of these guidances will be aiding sponsors with transition from the current guidance — Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (2009).

Communication

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! Published 2009 Dec 8. This offer is only good through July 31st, so order yours now! Behav Brain Funct.

Labelling

Pharmaceutical Technology

OCTOBER 5, 2008

Like in many other sectors, China and India are the ones labelled as those which will lead the expansion. Takeda is the largest pharmaceutical company in Japan and according to analysis by Global Insights has patents soon to expire on its best-selling products Prevacid (in 2009) and Actos (in 2111).

Pharmaceutical Companies

Putting Patients First Blog

DECEMBER 5, 2024

Real-world case studies demonstrating how PPI has influenced decisions, such as targeted approvals or label modifications, would clarify its practical utility. 20 Specialized patient labeling should describe patient preferences for specific benefits and risks, tailored to the population most likely to use the device. 1 (2009): 2029.

Labelling

The Thyroid Pharmacist

JUNE 30, 2023

Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. LDN was one of the first interventions that I had tried on my thyroid journey back in 2009. These include Crohn’s, MS, and Hashimoto’s, as well as other immune system-related conditions such as cancer and HIV/AIDS.

Compounding

The Thyroid Pharmacist

AUGUST 18, 2023

Safety and efficacy of curcumin versus diclofenac in knee osteoarthritis: a randomized open-label parallel-arm study. January 2009. [26] 2019;69:1-8. doi:10.1016/j.nutres.2019.05.001; 2019.05.001; Shep D, Khanwelkar C, Gade P, Karad S. 2019;20(1):214. Published 2019 Apr 11. Published 2013 Dec 6. Rooting out Misconceptions.

Dosage

The Thyroid Pharmacist

AUGUST 19, 2022

Berberine containing quadruple therapy for initial Helicobacter pylori eradication: An open-label randomized phase IV trial. link] Published April 6, 2009. Published 2015 Jul 16. doi:10.1186/s12906-015-0775-4. Zhang D, Ke L, Ni Z, et al. Medicine (Baltimore). 2017;96(32):e7697. doi:10.1097/MD.0000000000007697. 0000000000007697.

Health and Personal Care Stores

PharmaShots

FEBRUARY 21, 2023

Market Cap: $8.57M Founded Year: 2009 Total Employees: ~40 Headquarters: Oslo, Norway Stock Exchange: OSE Nordic Nanovector is a biotech company committed to developing and commercializing antibody-radionuclide conjugates to address significant unmet medical needs. In Aug’21, the US FDA cleared QSam’s IND application for CycloSam.

Dosage

RX Note

FEBRUARY 11, 2024

Laboratory analysis of some homeopathic remedies found greater amounts of Atropa belladonna (deadly nightshade, an anticholinergic agent) than claimed on the label. . * UpToDate does not recommend OTC (including homeopathic remedies) or prescription-strength topical analgesics (e.g.,

Adverse Reactions

The Thyroid Pharmacist

JULY 29, 2022

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S. 2010;20(7):755-761.

Health and Personal Care Stores

The Thyroid Pharmacist

SEPTEMBER 12, 2022

Resorcinol is restricted in all cosmetics in Japan, and the EU limits concentrations and requires warning labels. To avoid this chemical, look for the following ingredients on your product labels: resorcinol, 1,3-benzenediol, resorcin, 1,3-dihydroxybenzene (m-hydroxybenzene, m-dihydroxyphenol). 2009 Apr;23(4):767-73. Eye (Lond).

Health and Personal Care Stores

PharmaShots

APRIL 13, 2023

2009 was a challenging year for multinational companies due to the recession and currency fluctuations Johnson & Johnson's performance graph declined by 2.9% Despite a challenging year, Johnson & Johnson acquired Cougar and Elan Pfizer's 2009 performance was significant as compared to 2008 with the addition of Wyeth.

Biosimilars

European Pharmaceutical Review

SEPTEMBER 22, 2023

Lecanemab (BAN2401) infusion reactions and immunogenicity: results from randomized phase 2 study and an open-label extension. Lowe SL, Duggan Evans C, et al. 2021 Donanemab (LY3002813) Phase 1b Study in Alzheimer’s Disease: Rapid and Sustained Reduction of Brain Amyloid Measured by Florbetapir F18 Imaging. Vellas B, Black R, Thal L, et al.

Immunization

pharmaphorum

FEBRUARY 26, 2021

Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. The litigation was settled in 2009, when Boston Scientific agreed to pay $716 million in September and an additional $1.73 Johnson’s Baby Powder also went on sale during this year and was extremely successful.

Vaccines

The Thyroid Pharmacist

JULY 20, 2023

A reinvestigation using Fe-labelling and non-invasive liver iron quantification. May 17, 2009. 1989;114(4 Pt 1):657-663. doi:10.1016/s0022-3476(89)80717-6 [42] Nachtigall D, Nielsen P, Fischer R, Engelhardt R, Gabbe EE. Iron deficiency in distance runners. Int J Sports Med. 1996;17(7):473-479. Wu M, Xu Y. SpringerLink. 2021;13(6):1956.

Health and Personal Care Stores

The Thyroid Pharmacist

FEBRUARY 10, 2023

To date, vaginally-applied DHEA is still only available through prescription, either as Intrarosa® or an off-label customized prescription. 2009-0041; Thyroid Disorders and Men’s Sexual Health. 2009-0041. [28] doi:10.1186/s12967-020-02519-1 [11] Krassas GE, Poppe K, Glinoer D. Thyroid function and human reproductive health.

Dosage

pharmaphorum

FEBRUARY 5, 2021

The FDA did go on to add warning labels in the following years and eventually decided to require a class-wide monitoring programme, with training for doctors. He’s been closely linked to the full time job since Biden was sworn in and formerly worked as principal deputy commissioner of the FDA from 2009 until 2011. Dr Janet Woodcock.

Vaccines

EMCrit Project

JULY 15, 2025

intensivist, CCRN, etc.) Δ Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* All EMCrit Content is a product of EMCrit LLC; Copyright 2009-. All PulmCrit and IBCC Content are a product of Farkas Medical LLC; Copyright 2009-. Your Job (i.e. Your Job (i.e.

Labelling

EMCrit Project

JUNE 30, 2025

Subscribe Login Notify of new follow-up comments new replies to my comments Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* intensivist, CCRN, etc.) Δ Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* Your Job (i.e. Your Job (i.e.

Labelling