European Pharmaceutical Review

JULY 25, 2022

These may be mislabelled or produced in fake packaging and, most dangerously, there is no regulation around their manufacture. As a result, the development of advanced packaging-level tokens has led to watermarking techniques; invisible, encoded data that requires specialist verification software. Supply-chain visibility.

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Packaging Pharmaceutical Manufacturing Online Pharmacies 104

European Pharmaceutical Review

APRIL 10, 2025

These chemicals are everywhere and have been used in many ways over the decades, bringing a range of benefits from water- and stain-resistant coatings and firefighting foams to nail polish and food packaging. However, the world is now learning they are also persistent pollutants that contaminate our soil, water and air. www.eea.europa.eu.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Packaging Documentation Communication 52

Pharma Packaging Solutions

MARCH 19, 2019

We are ready to discuss challenging packaging issues, upcoming serialization and aggregation deadlines, and more. We look forward to 2019 challenges and working on them with you. appeared first on Pharma Packaging Solutions. We are in the Lotte Palace at 455 Madison Avenue in Suite 5009 (same suite as last year).

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Packaging 40

European Pharmaceutical Review

APRIL 8, 2025

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. International Council for Harmonisation (ICH), 2019. International Council for Harmonisation (ICH), 2012.

Documentation 52

Documentation Packaging Pharmaceutical Manufacturing 52

pharmaphorum

DECEMBER 10, 2021

Intercept first filed for approval of OCA in the EU and US in 2019, but the FDA finally turned down the US application in June 2020 after twice extending what should have been a swift six-month review of the drug. Shares in Intercept slipped around 15% after it announced the news.

Packaging 98

Packaging 98

pharmaphorum

APRIL 21, 2021

Advair lost US patent protection in 2010 and exclusivity on the Diskus inhaler went in 2016 – but it took until February 2019 for the FDA to approve a generic from Mylan, now part of Viatris. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

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Packaging 59

ALiEM - Pharm Pearls

FEBRUARY 8, 2023

Because nail glue is often packaged in small containers identical to eye drop bottles, patients can mistake the nail glue for ophthalmic drops — especially those with visual impairment [6]. Characteristics of ocular nail glue exposures reported to the National Electronic Injury Surveillance System during 2000-2019.

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Packaging 130

pharmaphorum

OCTOBER 13, 2020

Launched in February 2019, Numan claims to help men take action with their health and wellbeing. Shah headed up NHSX , the government agency digitising the UK’s health service, from March to October 2019. Novator partner Birgir Már Ragnarsson will also join Numan’s board as part of the funding package.

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Packaging 52

Pharmaceutical Technology

JULY 26, 2022

A complete analytical, preclinical and clinical data package is part of the BLA and MAA submissions. In 2019, Sandoz and Polpharma Biologics signed an international commercialisation agreement for natalizumab. This indication is already approved by the regulatory agency for Tysabri.

Biosimilars 64

Biosimilars Packaging 64

European Pharmaceutical Review

APRIL 21, 2023

The leaked draft of the European pharmaceutical package is promising on this point as it states that marketing authorisation may be refused if the ERA is not completed or risk mitigation measures are insufficient, and that an ERA programme should be set up for medicines that were authorised before the introduction of the ERA. cited 23Apr].

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Pharmaceutical Companies Pharmaceutical Companies Packaging 98

Pharmaceutical Technology

JUNE 19, 2023

It is critical to understand the supply chain, plan your packaging, storage and distribution lanes, then test the entire process before patient shipments go live. Products are stored and packaged in a dedicated suite by a dedicated team,” explains MacNeir. The requirements When handling personalised medicines, time is of the essence.

Packaging 52

Packaging Compounding Communication Pharmaceutical Companies 52

European Pharmaceutical Review

SEPTEMBER 26, 2023

Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. The regulatory package submitted to the EC included evidence derived extensive analytical characterisation. Sandoz has the rights to commercialise and distribute it in all markets under the deal.

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Biosimilars Dosage Packaging 59

Pharmaceutical Business Review

JULY 21, 2023

CYFENDUS vaccine was the subject of a pre-emergency use authorisation package submitted to the US FDA in December 2018. In 2019, the US government commenced procuring this product for national preparedness efforts.

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Vaccines Immunization Immunity Packaging 52

Pharmaceutical Technology

JANUARY 20, 2023

In addition, a paper published in 2019, concluded that the pharmaceutical industry produced 48.55 While using high-capacity aircraft and minimal packaging reduces weight and increases capacity for vital products by using fewer flights.

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Pharmaceutical Companies Pharmaceutical Companies Packaging Communication 142

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.

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Compounding Sterile Compounds Packaging Labelling 52

Pharmaceutical Technology

MARCH 30, 2023

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

pharmaphorum

DECEMBER 31, 2021

The complaint against Teva was brought in 2019, and accused the company of aggressively marketing opioid painkillers across New York and misleading the public about the harmful effects of the drugs. New York was also one of the states that is holding out against a proposed $4.5

Packaging 52

Packaging Immunization Immunity 52

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. 2019 [cited 2023Feb]. the enteric coating and the capsule dissolve.

Biosimilars 105

Biosimilars Diabetes Immunization Immunity 105

European Pharmaceutical Review

FEBRUARY 6, 2024

Update January 2019: This Q&A has been superseded by the Guideline on The Sterilisation of the medicinal product, active substance, excipient and primary container. These are discussed in EU GMP guide annexes: Supplementary requirements: Annex 1: Manufacture of sterile medicinal products. What is the maximum bioburden level?

Dosage 52

Dosage Packaging 52

Putting Patients First Blog

AUGUST 2, 2023

Since its first iteration, PAHPA has been reauthorized every five years — once in 2013 and again in 2019 — in a typically bipartisan manner; the current iteration of PAHPA expires on September 30 of this year.

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Packaging 52

FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Whether a firm used the 10-day call and/or an SIR, it should include any prior feedback from those interactions with FDA in the AI response and describe how and where in the AI response package the prior feedback was addressed.

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Documentation Packaging Communication Labelling 75

RX Note

JUNE 8, 2023

In the past, package inserts were not always reliable sources of information regarding medication safety during lactation. NOTE: LactMed apps for Android and iOS devices were retired on 16 December 2019. Notable exceptions are heparin and insulin which are too large to cross biological membranes.

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Labelling Packaging 40

Pharmacy Friday Pearls

SEPTEMBER 23, 2022

The package insert for Kcentra® indicates dosing is to be based on both INR and weight, resulting in possible confusion and delayed time to administration of Kcentra®. Dosing According to Package Insert. Kcentra (prothrombin complex concentrate [Human]) [package insert]. Am J Emerg Med 2019;X(XX):1-4. References.

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Packaging Hospitals 40

pharmaphorum

NOVEMBER 29, 2021

iii] It’s no longer just about the company, compensation package and secondary benefits (e.g., He joined the company in 2015, moving to the position of head of HR medical devices North America in 2019, before taking up his current role in 2021. gym membership).

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Communication Packaging Pharmaceutical Companies Pharmaceutical Companies 98

Pharma in Brief

SEPTEMBER 1, 2022

These reforms commenced with August 2019 amendments to the Patented Medicines Regulations (the Amendments ) and accompanying changes to the Board’s Guidelines. A reduced package of Amendments comes into force. In this post, we summarize the current status of reforms to the Patented Medicine Prices Review Board ( PMPRB ).

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Packaging 59

pharmaphorum

JUNE 1, 2021

Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain. However, traceability and security measures focused on the packaging level may not be enough to protect patients.

Online Pharmacies 52

Online Pharmacies Dosage Packaging Pharmaceutical Companies 52

European Pharmaceutical Review

JUNE 24, 2022

However, a Gupta study from 2019 on what companies spend money on when developing new drugs showed that out?of?pocket It is too early to say because we have not seen the whole package of measures yet. Amsterdam: Gupta Strategists; 2019. pocket expenses account for only seven percent of the overall cost of developing drugs.

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Compounding Drug Development Drug Pricing Dosage 105

GMPSOP

JUNE 28, 2024

In the five years between 2019 and 2023, the FDA issued the following warning letters, closely related to ineffective deviation investigation. Packaging/labeling/Misbranding: 41 warnings vi. In 2019 and 2020, warning letters were issued for “Adulterated Food and Supplements” at 36% and 33%, respectively.

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Documentation Packaging Labelling Pharmaceutical Manufacturing 59

National Association of Boards of Pharmacy

NOVEMBER 6, 2024

Launched in 2019, NABP’s Specialty Pharmacy Accreditation was created to accredit pharmacies providing advanced levels of pharmacy services and disease management tools for patients taking medications that require special handling, storage, and dispensing requirements.

Specialty Pharmacies 45

Specialty Pharmacies Packaging Documentation 45

HealthPartners

MAY 6, 2021

According to a 2019 Pharmacy Benefit Management Institute (PBMI) report on specialty drug benefits, 88% of employers currently receive some of these rebates from their PBM as part of their pharmacy benefit contracts. Let’s start simple: What is a prescription drug rebate?

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Mail-Order Pharmacies Drug Pricing Packaging 52

Pharmaceutical Technology

MARCH 10, 2023

Based on the further deteriorating economic situation, the MoH provided a pricing resolution that reduced subsidies on a range of raw materials used for local production and packaging of medicines.

Drug Pricing 52

Drug Pricing Packaging 52

RX Note

JULY 1, 2023

Unit Dose System The unit dose system is characterized by medications contained in unit dose packages , dispensed in ready-to-administer form, with not more than a 24-hour supply delivered or available on the patient care unit at any time.

Hospitals 40

Hospitals Packaging Clinic Management Inpatient 40

STAT

OCTOBER 27, 2022

This calls for celebration with a cup of stimulation, and we are opening a new package of Pumpkin Spice for the occasion. The investigation began in February and covers 2017, 2018, and 2019. Autumn, after all, is in full swing. Meanwhile, our ever-growing to-do list requires attention. Sound familiar?

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Packaging Vaccines 240

NY Times

SEPTEMBER 21, 2021

The pandemic has exposed flaws in services for people who can’t easily access a drive-through window for Covid shots or testing or can’t read prescription labels.

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Specialty Pharmacies Labelling Packaging 90

RX Note

JUNE 5, 2023

mg/mL oral suspensions extemporaneously compounded from tablets with three different vehicles and samples of each finished suspension were packaged in 120mL amber polyethylene terephthalate plastic prescription bottles and stored at 5 and 25°C in the dark. Sorption to PVC Container Regarding to clonazepam 0.1

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Compounding Labelling Packaging Hospitals 52

The Thyroid Pharmacist

DECEMBER 6, 2023

The key is to eat good fats found in fish, olive and coconut oil, and avocados; avoid bad (trans) fats, found in baked or fried goods, packaged cookies, certain cereals, and hydrogenated oils. link] Accessed February 5, 2019.; Published 2019 Oct 11. Published 2019 Mar 3. doi:10.1155/2019/8796234; Westphalen, D.

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Immunization Immunity Adverse Reactions Packaging 98

European Pharmaceutical Review

JANUARY 13, 2025

Sustainable pharma packaging: breaking down the barriers to adoption Over two years it resulted in approximately 52,000 inhalers being returned, equating to approximately 305 tonnes of CO 2. To meet these commitments, our goal must be to deliver transparent, environmentally conscious solutions across all disease areas. 2024; 85: 1-9.

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Packaging Community Pharmacies Documentation Pharmaceutical Companies 52