FDA Law Blog: Biosimilars

MARCH 8, 2023

Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. For any major changes, additional time will be granted between the release of the implementation package and production deployment.

Packaging 59

Packaging Communication 59

European Pharmaceutical Review

FEBRUARY 7, 2023

Regulation of clinical trials Eight years following its adoption in 2014, the Clinical Trials Regulation 536/2014 (CTR) entered into application on 31 January 2022. Some of the current and anticipated proposals will not be adopted in 2023, or even before the end of tenure of the current European Commission in late 2024.

Packaging 117

Packaging Drug Development 117

pharmaphorum

NOVEMBER 16, 2022

Given there have been no new therapies approved by the FDA for this indication since 2014, ELAHERE’s accelerated approval is a tremendous advance in the ovarian cancer treatment paradigm.”. Senior vice president and CMO at ImmunoGen, Dr Anna Berkenblit, said: “Platinum-resistant ovarian cancer is a notoriously challenging disease to treat.

Medical Schools 69

Medical Schools Packaging 69

Pharmaceutical Technology

MARCH 30, 2023

Broadening uses and secured full approvals Since its first approval in September 2014, Keytruda has achieved blockbuster status on the market. While the drug was granted accelerated approval in June 2019, it did not deliver on a key overall survival (OS) endpoint as part of its post-marketing data package.

Chemotherapy 52

Chemotherapy Packaging Documentation 52

RX Note

JUNE 5, 2023

No Added Sugar: No sugar or ingredient containing sugar was added during processing or packaging. Reduced Sugar: Has at least 25% less sugars than the regular version of the product. Also: less sugar, low in sugar or lower sugar.) Also: without added sugar or no sugar added.)

Packaging 52

Packaging Compounding 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

Pharmacy Joe

OCTOBER 25, 2023

The list was originally compiled and updated by John Mitchell, PharmD, who passed away on June 10, 2014. The list has since been maintained and updated by Thomas Land Publishers and is available for purchase as a wall chart on ISMP’s website.

Dosage 52

Dosage Inpatient Packaging Documentation 52

Pharmacy Friday Pearls

MARCH 28, 2022

Mion, 2014 Case report N=1 • Epinephrine then transition to norepinephrine • 58 year male, The cardiac rhythm turned into a ventricular fibrillation (VF). Epinephrine [package insert] Lake Forest, IL: Hospira, Inc.; 2014 Dec;32(12):1560.e1-2. 12.2] (P = 0.013) times higher in the EPI group compared to NE treated patients.

Dosage 40

Dosage Hospitals Packaging 40

European Pharmaceutical Review

MARCH 1, 2023

The mRNA is packaged and delivered to the cytoplasm of host cells, where it is translated into a protein that exerts the desired cellular effect. 2014 Nov 20; 56(4), 506‑17. mRNA therapeutics and their manufacture mRNA therapeutics contain a specific sequence (coding sequence), which corresponds to the gene or protein of interest.

Vaccines 111

Vaccines Packaging 111

European Pharmaceutical Review

FEBRUARY 22, 2023

The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. He has been a key member of the executive team, most recently serving as the company’s Vice President, Strategy since 2014. the enteric coating and the capsule dissolve.

Biosimilars 105

Biosimilars Diabetes Immunity Immunization 105

RX Note

JUNE 8, 2023

In the past, package inserts were not always reliable sources of information regarding medication safety during lactation. As a general rule, breastfeeding is considered acceptable when the relative infant dose is <10%.

Labelling 40

Labelling Packaging 40

Pharmaceutical Technology

SEPTEMBER 26, 2022

Given the conflict present in the eastern part of Ukraine from 2014, sponsors, investigators and logistics providers were prepared for potential disruption. By August, 28 foreign-sponsored, multi-country trials were affected, almost half with sites in Ukraine and Russia. [1].

Packaging 52

Packaging Documentation 52

pharmaphorum

MARCH 16, 2022

Moreover, no attendee data was available for physical symposia, whereas all virtual symposia packages provided full attendee metrics analyses. Accessibility to physical symposia was limited to approximately one hour, compared with three years on-demand for virtual symposia, or 26,280 times longer.

Communication 98

Communication Packaging 98

Syner-G

AUGUST 9, 2022

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. 5 clinical study reports. All clinical components of the NDA, including the Integrated Summaries of Efficacy and Safety (ISE and ISS), the Summaries of Clinical Efficacy and Safety (Modules 2.7.3

Documentation 40

Documentation Packaging Labelling 40

Syner-G

AUGUST 9, 2022

By early 2014, the Regulatory Operations group was fully operational and ready to offer electronic publishing services to IMPACT’s clients. During the last year, IMPACT has submitted several FDA meeting packages for this consultant as well.

Packaging 40

Packaging Documentation 40

HealthPartners

MAY 6, 2021

According to Pew Charitable Trust, between 2014 and 2016, PBMs more than doubled the income they earned from spread pricing (markups on drugs) and fees from drug manufacturers. They may reclassify them as something else such as admin fees, market share fees, clinical program fees or data management fees. Where do drug rebates go?

Mail-Order Pharmacies 52

Mail-Order Pharmacies Drug Pricing Packaging 52

European Pharmaceutical Review

DECEMBER 21, 2022

10 Diagnostics and biologics also heavily utilise carbon-based materials as constituting building blocks, processing aids, single-use reactors, or packaging materials. Chem Commun 2014, 50, 9650‒9652. Org Process Res Dev 2022, 26, 9, 2685–2693. Sherwood J, De bruyn M, Constantinou A, et al.

Compounding 97

Compounding Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 97

The Pharmacist Blog

MARCH 28, 2015

See Below which is an OLD pay scale from early 2014 and has been increased since (hospital where I currently work, which includes the outpatient retail techs): Pharmacy Assistant Pay Calculations: $14.50/hr Gets new job at a hospital inpatient pharmacy with a base pay as a new grad of $20.00/hr hr (based on my current employer pay scale).

Pharmacy Technician 52

Pharmacy Technician Hospitals Compounding Inpatient 52

RX Note

MAY 18, 2023

Interestingly, a 2014 study comparing bimatoprost 0.01% and bimatoprost 0.03% actually concluded that reductions in IOP from latanoprost baseline were larger with bimatoprost 0.01% than with bimatoprost 0.03%, and bimatoprost 0.01% had a more favourable tolerability profile. Safety and tolerability of brimonidine purite 0.1%

Packaging 52

Packaging 52

The Thyroid Pharmacist

AUGUST 19, 2022

25) A 2014 study looked at the co-occurring rates of autoimmune gastritis in people with Hashimoto’s, as autoimmune gastritis may contribute to the malabsorption of thyroid medication and require a person to need a higher dose of thyroid hormone. (26). MegaGuard and PyloGuard provide doses on the package. July 5, 2014.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunity Immunization Dosage 98

The Thyroid Pharmacist

JANUARY 27, 2023

Back in 2014 when I spent a year living in Amsterdam, Netherlands, I experienced a Hashimoto’s flare-up after having been in remission for some time. They usually charge by the minute or have discount session packages available. For this article, I’d like to focus on a solution that can help with detoxification.

Diabetes 98

Diabetes Immunization Immunity Packaging 98

Express Pharma

MARCH 12, 2025

It noted that US law requires complete manufacturing addresses to be printed on generic drug packaging and listed in the FDAs Orange Book database. IPA also addressed concerns regarding transparency in drug manufacturing locations.

Generic Medicine 66

Generic Medicine Process Improvement Dosage Pharmaceutical Manufacturing 66

Birth Control Pharmacist

SEPTEMBER 20, 2021

While not stated in the current package insert, data are emerging that support fewer breast tissue effects and breakthrough bleeding than older oral contraceptives. Nextstellis (Drospirenone and Estetrol) [package insert]. OUP Academic , Oxford University Press, 5 July 2014, academic.oup.com/carcin/article/35/11/2447/416699.

Adverse Reactions 52

Adverse Reactions Packaging Labelling Diabetes 52

European Pharmaceutical Review

JULY 22, 2024

Tubing or parts should be visually inspected to ensure quality before being installed; eg, verifying package integrity, sterilisation cycle indicators and ensuring bonnets or muffs are secured on the end of tubing. It is important to ensure that the area in which materials are set down or handled is cleaned or is amenable to sanitisation.

Packaging 52

Packaging 52

The Thyroid Pharmacist

JULY 29, 2022

Back in 2014, I found that my Hashimoto’s flared up after using a particular lip gloss; once tested, it came back as containing arsenic! . Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. Published March 2014. 2014 Aug;7(8):813-823.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

pharmaphorum

NOVEMBER 16, 2020

In his final message as head of the EMA, Rasi said the number of COVID-19 drugs and vaccines being developed by pharma companies is “encouraging,” and pointing to the agency’s pivotal role “in reviewing the available data packages to ensure that our usual high standards of safety, efficacy and quality are achieved and upheld.”.

Vaccines 64

Vaccines Packaging 64

The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. Follow package directions for each supplement. Sleep issues: I like to recommend Epsom salt baths, which contain magnesium that is absorbed through the skin (1 cup of salts per tub – follow package instructions, and don’t overdo it!), Published 2014 May 24. J Appl Microbiol. 2014;7:181-190.

Health and Personal Care Stores 99

Health and Personal Care Stores Immunity Immunization Compounding 99

RX Note

FEBRUARY 23, 2023

Figures - Elemental iron and calcium content?

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

The Thyroid Pharmacist

MARCH 10, 2023

Be sure to follow the package directions and your practitioner’s guidance to determine the right dosage for you. 2014 Dec;28(12):1897]. Published 2014 Jun 12. Published 2014 Aug 19. link] [13] Lee KB, Cho E, Kang YS. Phytother Res. 2014;28(11):1599-1605. doi:10.1002/ptr.5163; Iron in Restless Legs Syndrome. January 1997.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunity Immunization Dosage 98

The Thyroid Pharmacist

MARCH 7, 2025

In 2014, I suffered a sudden flare-up of my Hashimotos after starting to use a new lipstick. 10] Its not only found in obvious sources like plastic containers and packaging, but also in the lining of canned foods and drinks, receipts, toys, electronics, and household items. Published 2014 Jan 3. Springerplus.

Health and Personal Care Stores 59

Health and Personal Care Stores Labelling Immunity Immunization 59