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 64

Communication Documentation Labelling Pharmaceutical Companies 64

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 40

Labelling Pharmaceutical Companies Pharmaceutical Companies 40

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

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 40

Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 40

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 52

Communication Documentation Labelling Pharmaceutical Companies 52

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 56

Dosage Labelling Immunity Immunization 56

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.

Immunity 97

Immunity Immunization Vaccines Communication 97

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 40

Communication Drug Development Packaging Labelling 40

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 40

Pharmaceutical Companies Pharmaceutical Companies Labelling Diabetes 40

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 82

Labelling 82

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 40

Labelling Communication Mayo Clinic 40

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 98

Compounding Immunity Immunization Compounding Pharmacies 98

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 40

Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40

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 98

Dosage Compounding Labelling Diabetes 98

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 52

Health and Personal Care Stores Compounding Immunity Immunization 52

FDA Law Blog: Biosimilars

JANUARY 22, 2025

Wasserstein & Dara Katcher Levy Who among us, upon reading FDAs draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for Scientific Information on Unapproved Uses ) did not automatically think of Phil Collins classic song Sussudio ? By Jeffrey N. Other than anyone under 50, that is.

Labelling 59

Labelling Communication 59

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 98

Health and Personal Care Stores Immunization Immunity Dosage 98

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 98

Health and Personal Care Stores Immunity Immunization Labelling 98

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 95

Health and Personal Care Stores HIV Treatment and Prevention Agents Immunity Immunization 95

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 97

Documentation Hospitals Dosage Drug Pricing 97

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 98

Dosage Documentation Diabetes Labelling 98

RX Note

MARCH 31, 2025

Oral ivermectin (not registered in Malaysia and off-label use for scabies) is another first-line recommended regimen, however only for patients weighing more than 15 kg. Permethrin 5% is the drug of choice for patients 2 months old due to its low toxicity and high efficacy and is generally well tolerated.

Labelling 40

Labelling Community Pharmacies 40

RX Note

DECEMBER 25, 2024

In 2007, FDA changed the labelling requirement for warfarin, advising that a lower initial dose should be considered in people with certain genetic variations. Tramadol is metabolised by CYP2D6 to its active metabolite: 6-10% of Caucasians and 1-2% of Asians lack CYP2D6 and may not obtain pain relief.

Labelling 40

Labelling 40

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 119

Vaccines Biosimilars Labelling 119

The Thyroid Pharmacist

NOVEMBER 8, 2024

After being diagnosed with Hashimoto’s in 2009, I spent a lot of time, money, and resources on trying to figure out my root cause. 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!

Immunity 72

Immunity Immunization Diabetes Adverse Reactions 72