FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

Documentation 59

Documentation Communication 59

European Pharmaceutical Review

NOVEMBER 24, 2022

With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.” Several branded medicines are available that feature holograms on the packaging or in the blister pack.”

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Packaging Labelling Documentation Dosage 111

Putting Patients First Blog

JULY 2, 2024

As noted in our previous communications, while the NHC would prefer a more traditional Notice and Comment rulemaking opportunity that would ensure the Agency directly responds to stakeholder feedback, we welcome this opportunity to express our reactions to CMS’ thinking on the negotiation program.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

FDA Law Blog: Biosimilars

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment.

Labelling 64

Labelling Communication Documentation 64

National Association of Boards of Pharmacy

JULY 19, 2024

On June 12, 2024, Food and Drug Administration (FDA) issued exemptions for certain dispensers and in limited scenarios, their trading partners, from certain requirements of section 582 under the Food Drug and Cosmetic Act (FD&C Act) until November 27, 2026. FDA recommends this be based on the November 2024 expected employee filings.

Pharmacy Technician 45

Pharmacy Technician Documentation Communication Packaging 45

Viseven

SEPTEMBER 18, 2024

By the end of 2026, the company will be able to analyze two million genomes. Cloud computing facilitates effortless collaboration Cloud computing makes it easier for life sciences companies to communicate and collaborate globally. This innovative approach has brought more than 40 successful drug discovery projects to AstraZeneca.

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Communication Vaccines Pharmaceutical Companies Pharmaceutical Companies 52

Putting Patients First Blog

SEPTEMBER 3, 2024

The NHC observed significant frustration with the portal during the IPAY 2026 process, where many participants found it difficult to navigate or understand how to properly submit their input. Additionally, the NHC recommends including questions that explore how these access challenges were communicated and managed by health care providers.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52