Putting Patients First Blog

APRIL 7, 2025

NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics (PDF) April 7, 2025 Dockets Management Staff U.S. Sponsors must document how AI- generated safety signals are prioritized, validated, and communicated to regulators and health care providers.

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Corrections and Removals Under 21 CFR Part 806, manufacturers generally need to communicate corrections and removals (i.e., Stage 1 is scheduled to take effect on May 6, 2025. FDA plans to hold its next webinar on September 24, 2024, which will cover the labeling requirements that go into effect in Stage 2.

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Pharmaceutical Technology

DECEMBER 22, 2022

The new joint procedure will launch in Q1 2025 for oncology medicines and other advanced therapy medicinal products and extend to orphan drugs in 2028. However, he did point out that the joint assessment could be a useful way of narrowing down typically broad EMA label content to specific patient populations.

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Pharmaceutical Technology

JUNE 13, 2025

June 13, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The approval marks AbbVie’s therapy as the first and only DAA treatment approved for this patient group. Credit: © AbbVie Inc. All rights reserved. ” Mavyret had also secured a breakthrough therapy designation from the US regulator for acute HCV.

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Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. Comprehensive Transparency: AI applications should be fully disclosed, explainable, and accessible to patients and providers in layperson terms.

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Pharmaceutical Technology

JUNE 16, 2025

GlobalData Healthcare June 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Surovatamig’s global sales are projected to reach $138 million by 2031. GlobalData Healthcare June 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Surovatamig’s global sales are projected to reach $138 million by 2031.

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Labelling Communication Hospitals Vaccines 52

FDA Law Blog: Biosimilars

JULY 7, 2024

The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § 11] In the context of an LDT, it is unclear what FDA will include within the scope of “labeling” and what types of communications will be considered “claims.”

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FDA Law Blog: Biosimilars

JULY 9, 2024

If FDA determines that a waiver will be issued, it may consider public communications about the decision. Since it is only the submission of the plan that is required by law, how, if at all, will FDA communicate that a plan does not meet the requirements for submission? Some unanswered questions remain.

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Pharmaceutical Technology

JUNE 16, 2025

Robert Barrie June 16, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Elevidys is the only gene therapy approved in US for DMD. By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. Dragon Claws via Shutterstock.

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PharmaTech

JUNE 12, 2025

Image Credit: © Tada Images - stock.adobe.com In a June 10, 2025 update, FDA posted seven updated Warning Letters, issued between the beginning of 2025 and the present, to its online database, which stores more than 3400 such letters dating back to 2020 (1). American Behavioral Research Institute Boca Raton, Fla. –

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ID Stewardship

DECEMBER 11, 2024

With Twitter changing to X in mid-2023 and subsequently in the end of 2024 many folks from the IDtwitter community moving over to Bluesky, the game is certainly ever-changing. I wonder if this will cause us to be more fragmented as a group in 2025 and if Bluesky will really have sticking power. Mastodon sure did not.

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Pharmaceutical Technology

JUNE 13, 2025

Robert Barrie June 13, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook mRESVIA is the second approved product in the US for Moderna, along with its Covid-19 vaccine Spikevax. This usually begins around November and peaks in the mid-Winter months. Give your business an edge with our leading industry insights.

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FDA Law Blog: Biosimilars

MARCH 30, 2025

Livornese & Ricardo Carvajal On March 18, 2025, the U.S. Encouraging Transparency : FDA is working closely with manufacturers to ensure clearer labeling and increased transparency regarding ingredients and nutritional information on formula packaging. By Charles D. Snow & Deborah L.

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Pharmaceutical Technology

JUNE 6, 2025

Robert Barrie June 6, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook NHS England estimates that nearly 2.5 Figures published in May 2025 by NHS England estimated there were nearly 2.5 Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults.

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Pharmacy Times

JUNE 5, 2025

Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. 1-3 Detect-A-Dose Lid Label Covers. 4 Detect-A-Dose features a contrasting black and white pattern on the underside of its label to make missing doses for patients apparent to pharmacists. REFERENCES 1.

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2025

Labeling Labeling Section VII Risk Assessment Risk Management File of Software Documentation Section VIII Data Management Data for development: Software Description of Software Documentation Data for testing: Performance Testing Section IX Model Description and Development Software Description Section X.A

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FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. By Allyson B. Mullen & Jeffrey N.

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FDA Law Blog: Biosimilars

MAY 13, 2025

Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with comparably developed nations. (We note our departure from more light-hearted content and absence of musical references. Please bear with us.)

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