Eye on FDA

AUGUST 2, 2022

By 2002, the number had dropped to 28, reviving somewhat by the end of that decade when it reached 52 in 2010. But when it comes to enforcement things have changed greatly over the years. In 1998, there were 156 letters issued in a single year. So far this year, we are at 4, which is a pretty good clip these days.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

Pharmaceutical Technology

APRIL 27, 2023

Sanofi markets avalglucosidase alfa as Lumizyme in the US to treat LOPD since its approval in 2010. Sanofi’s Nexviazyme generated €196m ($215m) in global revenues in 2022, while Lumizyme was associated with €958m ($1.05bn) according to the company’s full-year report.

Labelling 52

Labelling 52

ID Stewardship

MARCH 12, 2023

BCPS, BCIDP Article Posted 12 March 2023 As a pharmacist serving as a preceptor to students and residents in the area of infectious diseases since 2010, I have always been on the hunt for good infectious diseases journal articles for my learners to read. Authored by: Timothy P. Gauthier, Pharm.D.,

Medication Guidelines 119

Medication Guidelines Documentation Labelling Hospitals 119

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

RX Note

MARCH 23, 2023

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

Compounding 52

Compounding Sterile Compounds Packaging Labelling 52

RX Note

MARCH 3, 2024

Aromatase inhibitors, e.g. letrozole, anastrozole - Off-label use Surgical management of endometriosis is indicated for treatment of severe pain or infertility. 114: management of endometriosis, 2010 NICE Endometriosis: diagnosis and management, 2017 External Links Therapeutic Guidelines - Endometriosis Practice bulletin no.

Labelling 40

Labelling 40

RX Note

JUNE 12, 2023

To ensure safe maintenance of thyroid hormone levels, authorities are adopting stricter potency specifications for L-T4, the most stringent of these being 95-105% of the labelled dose over the whole shelf-life. Over-replacement and under-replacement of thyroid hormone can increase cardiovascular risk.

Dosage 52

Dosage Labelling 52

Pulses

AUGUST 31, 2023

Chandos Publishing; 2010:123-168. References Ley D, Parkes D, Walton G. 6-emerging technologies for learning. Web 20 and Libraries. Hamilton D, McKechnie J, Edgerton E, Wilson C. Immersive virtual reality as a pedagogical tool in education: a systematic literature review of quantitative learning outcomes and experimental design.

Medication Dispensing 78

Medication Dispensing Medication Labelling Packaging Labelling 78

RX Note

MARCH 25, 2023

Dermatology Use (Off-label) When used in melasma , the reported success rate is up to 89%, with results appearing as early as 8 weeks. Dosage varies, according to the heaviness and duration of bleeding: 1 to 1.5 g 3 or 4 times daily for the first 3-5 days of each cycle.

Dosage 40

Dosage Labelling 40

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). In 2010, the Pharmaceutical Services Division, Ministry of Health Malaysia (MOH) has implemented the Return Your Medicines Program.

Medication Dispensing 40

Medication Dispensing Community Pharmacies Hospitals Labelling 40

The Thyroid Pharmacist

DECEMBER 7, 2022

Several years ago, after reading research about all of the toxins commonly used in flame retardants (and learning about all of the many products in my home that contain these chemicals… somewhat of a shocking list), I looked at my mattress label, only to learn it contained one of the chief offenders. Labels (Furniture, Fabrics, and Carpet).

Health and Personal Care Stores 80

Health and Personal Care Stores Labelling Immunity Immunization 80

Syner-G

AUGUST 9, 2022

In 2010, following a referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a mid-size biopharmaceutical company to assist them with an upcoming NDA for a new chemical entity in the treatment of an orphan condition. Download a PDF of this case study. The Journey Leading to an Approved NDA.

Documentation 40

Documentation Packaging Labelling 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. FDA said they would produce a guidance by the end of 2010, but did not.

Communication 52

Communication Documentation Labelling Pharmaceutical Companies 52

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. 2010 [cited 2024May]. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. Available from: [link] Wyard M.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

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

Pharmaceutical Technology

OCTOBER 5, 2008

Like in many other sectors, China and India are the ones labelled as those which will lead the expansion. However, BMI forecasts that the market share for these low-cost products in Japan will double by 2010, adding almost $5bn in value to the sector.” This compares to a figure of 65% in China and 37.1%

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Labelling Diabetes 40

RX Note

JULY 14, 2023

Moreover, even after the MDI delivers the number of puffs stated on their label, it may look, taste and feel like it is still working, but the dose delivered may be very low. Handling of Inhaler Devices, 2010 suggested that re-priming should be done for MDIs that are not used for more than 2 weeks.

Packaging 52

Packaging Labelling 52

RX Note

SEPTEMBER 23, 2023

Handling of Inhaler Devices, 2010 suggested that re-priming should be done for MDIs that are not used for more than 2 weeks. Moreover, even after the MDI delivers the number of puffs stated on their label, it may look, taste and feel like it is still working, but the dose delivered may be very low.

Packaging 52

Packaging Labelling 52

RX Note

MARCH 23, 2023

Product should be labelled clearly and stored as recommended within the formula. Pharmacy personnel are reminded not to empirically change flavourings or suspending agents because they can affect the pH and stability of the product and result in an unstable product.

Compounding 52

Compounding Health and Personal Care Stores Hospitals Dosage 52

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! Published February 2, 2010. (My readers can use code IZABELLAWENTZ for 15% off all Starter Kits.) 27 April 2015. Accessed April 18, 2022.

Health and Personal Care Stores 85

Health and Personal Care Stores Packaging Labelling Compounding 85

The Nutrition Pharmacist

NOVEMBER 24, 2021

So, you could be cautious and select a supplement that contains activated folate, labelled as L-methylfolate or follinic acid. January 2010. Important – some people have a gene mutation that leads to a folate deficiency, as the body cannot convert folate to the activated form. References. RANZCOG College Statement: C-Obs 25 2014.

Labelling 40

Labelling Diabetes 40

PharmaState Academy

OCTOBER 25, 2023

a) 1995 b) 2000 c) 2010 d) 2015 5 / 20 In the United States, what is the maximum time period allowed by the FDA for a pharmaceutical company to respond to an unsolicited request for off-label information from an HCP?

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Labelling 52

Birth Control Pharmacist

SEPTEMBER 20, 2021

Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. 2010, pubmed.ncbi.nlm.nih.gov/21166370/. Food and Drug Administration website. Accessed April 2021. . Grossman Barr, Nancy. Managing Adverse Effects of Hormonal Contraceptives.” American Family Physician , U.S. National Library of Medicine, 15 Dec.

Adverse Reactions 52

Adverse Reactions Packaging Labelling Diabetes 52

PharmaShots

FEBRUARY 21, 2023

FAP-2286 (labeled with lutetium-177), a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP), is the company’s lead asset amongst radiopharma products.

Dosage 56

Dosage Labelling Immunity Immunization 56

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. Hawk, Kimberly A.

Labelling 40

Labelling Communication Mayo Clinic 40

The Thyroid Pharmacist

OCTOBER 28, 2022

Dose: While the label of the product recommends taking two capsules per day, I used higher doses, building up to four capsules, three times per day. The probiotic has been so successful in inducing remission, it has been labeled as a “medical food.” link] Published March 2010. thingsIlearnedthehardway). J Fungi (Basel).

Health and Personal Care Stores 105

Health and Personal Care Stores Immunity Immunization Grocery Stores 105

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. 2011;119(1):A16.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

The Thyroid Pharmacist

OCTOBER 25, 2022

Fibrocystic breasts used to be labeled as a disease, but given how common they are, they’re now simply referred to as “fibrocystic breasts.” (7) link] Published September 2010. Purification, Preliminary Characterization and Hepatoprotective Effects of Polysaccharides from Dandelion Root. 2017;22(9):1409. Published 2017 Aug 25.

Compounding 61

Compounding Mayo Clinic Labelling Immunization 61

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). Savage, MN: Lone Oak Publishing; 2010.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunity Immunization Labelling 98

The Thyroid Pharmacist

OCTOBER 27, 2023

Precautions Do not take more than the recommended dose on the label. If you’re experiencing these symptoms, reduce your dosage to ⅛ teaspoon daily, increasing usage slowly, as tolerated, to get to the recommended label usage. Published 2010 Jan 19. Another resource for high-quality supplements is PureRXO. 2010;3(1):188-224.

Health and Personal Care Stores 99

Health and Personal Care Stores Immunity Immunization Compounding 99

The Thyroid Pharmacist

JULY 7, 2023

In a study done in 2010, NAC and 15-Deoxy-Prostaglandin J2 (a fatty acid compound with antioxidant and anti-inflammatory properties) exerted a protective effect against autoimmune thyroid destruction in vivo. [47] Research has shown that people with Hashimoto’s disease have lower levels of glutathione. Indian J Endocrinol Metab.

Immunity 105

Immunity Immunization Diabetes Dosage 105

Pharmaceutical Technology

DECEMBER 4, 2022

Humira is indicated for 10 adult and pediatric conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, as per its label. Others are made by big pharma giants like Boehringer Ingelheim , Novartis , or Pfizer , which has raised the expectations for a competitive market. .

Biosimilars 104

Biosimilars Labelling Communication Hospitals 104

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

JANUARY 20, 2023

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In 2010 Jan;76(1):7-19; Lee HW, Kim YH, Kim YH, Lee GH, Lee MY. 2010 Mar;62(2):145-55; Costa CARA, Quaglio AEV, Di Stasi LC. Complementary and Alternative Therapies and the Aging Population.

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunity Immunization 98

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. 2010 Oct;31(5):702-55. 2010 Oct;31(5):702-55. Published 2010 Aug 6. 2020;18(1):349. Published 2020 Sep 14. doi:10.1186/s12967-020-02519-1 [11] Krassas GE, Poppe K, Glinoer D.

Dosage 98

Dosage Documentation Diabetes Labelling 98

ID Stewardship

FEBRUARY 12, 2025

coli labeled as susceptible in 2010 may be labeled as resistant in 2025. MIC breakpoints can change over time CLSI and other similar bodies change breakpoints periodically based on epidemiological data and other emerging information. This means that the same E. CLSI releases updates on which breakpoints are changing and why.

Labelling 52

Labelling 52

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 16] Even more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! From indoor pollutants like formaldehyde (yes, really!),

Health and Personal Care Stores 60

Health and Personal Care Stores Labelling Immunity Immunization 60