FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. Remarkably, manufacturers may not dispute a CMS notification.

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pharmaphorum

APRIL 16, 2021

Even with the vaccine roll-out, further waves of COVID infection and lockdowns mean these vital drivers of launch performance remain impacted in 2021, and even beyond. The longer term impact of 2020 on clinical trial activity, given widely documented pauses on trials, will only be evaluable in coming years.

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Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 95

Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Health Canada has also published a guidance document that contains additional information for drug sponsors.

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Vaccines Biosimilars Documentation 52

Pharmaceutical Technology

NOVEMBER 3, 2022

But since these generics or biosimilars are often not too profitable, manufacturers require incentives, say Beavers and Page. After all, there have been united efforts before, pointing to the EU-wide Covid-19 vaccine procurement strategy as a good example, he says. Improving the supply chain.

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Dosage Biosimilars Documentation Hospitals 111

RX Note

FEBRUARY 23, 2023

. - Drug registration number Medicines (Advertisement & Sale) Act 1956 and Regulations - To learn prohibitions of medicine advertisement and Medicine Advertisement Board Registration of Pharmacists Act 1951 and Regulations - Pharmacy Board Malaysia and legislation aspects of provisional, full and temporary registration Code of Ethics for Pharmacists (..)

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

Pharma in Brief

JANUARY 10, 2024

It now contemplates IT platforms ( e.g. , social media) and applies to drugs for use in humans as well as medical devices, natural health products, biologics, vaccines, and animal health products. The Guidance was last updated in 2005. Rare disease strategy. billion over three years to help increase drug access and affordability (see here ).The

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Drug Pricing Documentation Biosimilars Vaccines 52

European Pharmaceutical Review

FEBRUARY 17, 2023

The document contains an overview of the agency’s key recommendations in 2022. The highlights document summarised the most important recommendations on vaccines and treatments for COVID-19 and for mpox (monkeypox). An overview of some of the most notable safety-related recommendations is also included in the document.

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Documentation Biosimilars Diabetes Vaccines 98

Express Pharma

FEBRUARY 10, 2025

India trends: The power of AI and data analytics is ushering generative AI, along with AI and ML, into the Indian biopharma industry, contributing to areas such as disease understanding and vaccine development. India is streamlining processes for faster approvals of biologics and biosimilars, aiming to speed up access to effective therapies.

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