Safe Biologics

DECEMBER 3, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. A 2021 survey of 401 U.S state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber. It is also opposed by the majority of physicians, in the U.S.

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Biosimilars Labelling Drug Pricing Packaging 130

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The amendments contemplate labelling flexibilities for special containers. On-site Evaluations. Public Comments.

Labelling 98

Labelling Packaging Biosimilars 98

Express Pharma

MAY 9, 2023

Whereas proper disposal of unused medications, as well as initiatives to reduce packaging waste, chemical waste, and improve recycling programmes, will aid in pro-actively addressing this challenge. This may involve the use of eco-friendly raw materials, green manufacturing processes, and eco-friendly packaging.

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Packaging Labelling Pharmaceutical Manufacturing Research Laboratories 98

Pharma in Brief

DECEMBER 3, 2020

continue to exclude COVID-19 drugs from brand-name assessments, including a look-alike/sound-alike assessment and labeling mock-ups, at the time of submitting an NDS. This interim order will expire on March 18, 2021 as will any device authorizations issued under the interim order. Subsequent entry drugs (i.e.,

Vaccines 98

Vaccines Labelling Biosimilars Packaging 98

Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. However, S.6 This would inappropriately limit the FDA’s authority to determine what data is scientifically appropriate for a particular biosimilar to provide in order to receive the designation.

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Biosimilars Drug Pricing Packaging Labelling 130

Safe Biologics

DECEMBER 6, 2023

A 2021 survey of 401 U.S REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert.

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Biosimilars Packaging Labelling Drug Development 130

FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. Devices can have both a UPC code and a UDI on their label and package. Emphasis added.)

Labelling 45

Labelling Packaging Documentation 45

pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

Customer Service 52

Customer Service Labelling Packaging 52

Pharmaceutical Technology

JULY 14, 2022

Pharmaceutical companies regularly outsource different steps of drug manufacturing processes like parenteral manufacturing and packaging, solid dose, and small molecule or biologic active pharmaceutical ingredient (API) production, among others. Several companies have been charged with manufacturing different components of J&J’s vaccine.

Vaccines 52

Vaccines Packaging Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

OCTOBER 1, 2020

CTI’s stock more than doubled on the news that it will complete a ‘rolling’ application for the JAK2/IRAK1 inhibitor in the first quarter of 2021, setting up a possible approval before the end of the year, with analysts at JMP suggesting the shares have the potential to rise another 100%.

Packaging 52

Packaging Labelling 52

European Pharmaceutical Review

SEPTEMBER 2, 2022

CHMP & EUnetHTA parallel Scientific Advice: Qualification of a Framework and “Points to consider” for method selection along with five methods for performing patient preference studies to inform regulatory and HTAbody medical product decision-making; November 2021. Available from: [link]. US Food and Drug Administration.

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Adverse Reactions Documentation Medical Schools Packaging 96

European Pharmaceutical Review

FEBRUARY 23, 2023

11 Future methods are likely to require samples being collected, labelled, filtered and processed to obtain their spectra. Label-free, rapid and quantitative phenotyping of stress response in E. Nat Rev Methods Primers, 2021; 1, 80: [link] Chevin L, Hoffmann A. This is particularly important for commonly used bacteria such as E.

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Labelling Packaging Drug Development 121

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.

Documentation 75

Documentation Packaging Communication Labelling 75

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. Results from the first open-label, single-centre study of RT-101,6 which was conducted in Australia, were reported at the start of 2020. Top companies and drugs by sales in 2021.

Biosimilars 105

Biosimilars Diabetes Immunity Immunization 105

Pulses

AUGUST 31, 2023

2021:55-77. Cross reality (XR): Challenges and opportunities across the spectrum. Innovative learning environments in STEM higher education: Opportunities, challenges, and looking forward. Onime C, Uhomoibhi J, Wang H, Santachiara M. A reclassification of markers for mixed reality environments. Campus-wide information systems.

Medication Dispensing 78

Medication Dispensing Medication Labelling Packaging Labelling 78

Birth Control Pharmacist

SEPTEMBER 20, 2021

new combined oral contraceptive was approved by the FDA (Nextstellis®) in April 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. Accessed June 25, 2021. Accessed April 2021. . Accessed June 25, 2021.

Adverse Reactions 52

Adverse Reactions Packaging Labelling Diabetes 52

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

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

European Pharmaceutical Review

FEBRUARY 14, 2024

Flexibility in packaging and label design may also be necessary, particularly where the physical dose size may require to be modified due to potency variations or multiple units may requiring dosing to achieve the target dose. 2021; 19:100306 4. Progresses on Bacterial Secretomes Enlighten Research on Mycoplasma Secretome.

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Dosage Packaging Labelling Compounding 97

Quality Matters

APRIL 20, 2023

Quality across the product lifecycle The role of standards goes far beyond the drug manufacturing process – from the sourcing of raw materials to packaging, labeling, distribution, and point-of-care administration – to help ensure quality across the pharmaceutical product lifecycle.

Biosimilars 52

Biosimilars Labelling Vaccines Generic Medicine 52

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The absence of standards was a focal point of the Cellular, Tissue and Gene Therapies Advisory Committee Meeting in September 2021 that was convened to discuss the toxicity risks of AAV vector-based gene therapy products.

Packaging 59

Packaging Documentation Labelling Communication 59

Quality Matters

APRIL 26, 2023

Quality standards and related tools – supported by appropriate regulatory capability and enforcement – can help promote quality across the pharmaceutical product lifecycle, from the sourcing of active and inactive ingredients to packaging, labeling, distribution, and point-of-care administration.

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Prescription Filling Generic Medicine Packaging Labelling 52

GMPSOP

JUNE 28, 2024

Packaging/labeling/Misbranding: 41 warnings vi. Failure to comply with regulations was the biggest (30%) reason for warning letters in 2021. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. CGMP Deviation: 39 warnings ii. Adulterated API: 39 warnings iv.

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Documentation Packaging Labelling Pharmaceutical Manufacturing 59

Quality Matters

OCTOBER 13, 2021

There are also related standards that address a wide range of topics such as packaging, storage and distribution of medicines, the preparation of compounded medicines and prescription labeling. josh.levin@usp.org Wed, 10/13/2021 - 13:07 Supply Chain

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Adverse Reactions Prescription Filling Compounding 52

PharmaShots

MARCH 9, 2023

Designation: Chief Commercial Officer (CCO) and President Award & Nominations: She has her mention in Fortune’s “Top 50 Most Powerful Women” in 2020, 2021, and 2022 ranking 16th, 11th, and 13th respectively. Other Affiliations: She is a fellow of the Royal Society (May 2021) associated with Merck.

Clinical Pharmacology 40

Clinical Pharmacology Immunity Immunization Pharmaceutical Companies 40

The Thyroid Pharmacist

NOVEMBER 11, 2022

It turns out that many of the ingredients in laundry detergent aren’t listed on the label (and can irritate one’s skin!), Wellnesse – This new 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!

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Labelling Packaging 98

The Thyroid Pharmacist

JULY 29, 2022

In 2021, our family moved back to sunny Los Angeles, CA, a big city far away from our home in the mountains of Colorado, but close to the beach and airport, so I was inspired to focus on a different type of outdoor air quality. For sunscreens and other over-the-counter drugs, fragrances must be identified on the label.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

PharmaShots

APRIL 5, 2023

Udenyca is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation The approval was based on the comprehensive analytical data package, along with a PK, PD, and immunogenicity study.

Biosimilars 49

Biosimilars Packaging Labelling Hospitals 49

The Thyroid Pharmacist

AUGUST 19, 2022

MegaGuard and PyloGuard provide doses on the package. 2021 Jun 12;273:113961]. Berberine containing quadruple therapy for initial Helicobacter pylori eradication: An open-label randomized phase IV trial. I suggest trying them individually, or using a combination of the three. 39,64-67). pylori I had after the birth of my son.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunity Immunization Dosage 98

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night. 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

OCTOBER 27, 2023

Follow package instructions. Follow package directions for each supplement. 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.

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Health and Personal Care Stores Immunity Immunization Compounding 99

Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

Packaging 59

Packaging Vaccines Labelling Communication 59

Pharmaceutical Technology

JANUARY 15, 2023

While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children.

Labelling 52

Labelling Packaging Communication Diabetes 52

Pharmaceutical Technology

JUNE 20, 2023

It plans to work with the FDA to plan new analyses and further develop a new application package. Data presented was drawn from the first 100 patients enrolled in F2G’s Phase IIb, single-arm, open-label trial (NCT03583164). 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

Packaging 52

Packaging Labelling Communication 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?!), 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.

Health and Personal Care Stores 61

Health and Personal Care Stores Labelling Immunity Immunization 61

Pharmaceutical Technology

FEBRUARY 27, 2023

Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.

Packaging 52

Packaging Chemotherapy Labelling Communication 52