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.

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PharmaShots

MARCH 1, 2023

In preclinical studies, HLX15 is highly similar to daratumumab Amgen Launches First Humira (adalimumab) Biosimilar Amjevita in the US Date- February 01, 2023 Product: Amjevita The company has launched Amjevita (adalimumab), the first biosimilar referencing blockbuster drug Humira on the US market for certain serious inflammatory diseases.

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FDA Law Blog: Biosimilars

JULY 10, 2023

The AI response package must respond completely to all parts of the deficiencies and include all information needed to address the deficiencies; in other words, a firm cannot submit a partially completed response package and plan to submit another AI response package at a later date to address remaining deficiencies.

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FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. By Douglas B. Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S.

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PharmaShots

APRIL 5, 2023

neovascular (wet) AMD Additionally, the availability of Byooviz could enable more patients to access this type of vision-saving therapy as it brings a sustainable and cost-effective anti-VEGF treatment to Canadian vision care Byooviz was approved in Canada for the treatment of multiple eye disorders.

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The guidance describes elements that would be required of VCS bodies for recognition of standards they adopt: openness (with meaningful opportunities to participate), balance (broad range of stakeholders), due process, an appeals process, and consensus.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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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.)

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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. 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.

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Vaccines Labelling Biosimilars Packaging 98

FDA Law Blog: Biosimilars

JUNE 12, 2023

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. AAFCO also publishes model regulations, including model pet food labeling regulations which states may adopt.

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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. the enteric coating and the capsule dissolve.

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Biosimilars Diabetes Immunity Immunization 86

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?

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 75

FDA Law Blog: Biosimilars

DECEMBER 14, 2023

As justification, the governors argued that state-regulated cannabis would require age verification, packaging and labeling standards, testing and warning symbols or statements, and allow for tracking products from seed to sale.

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