STAT

APRIL 24, 2025

HHS pauses CDC, FDA, and NIH communications with the public. White House Office of Management and Budget document leaked, revealing a plan to consolidate NIH into eight institutes and centers and cut its spending by about 40%. Trump administration orders closure of all federal DEI offices, workers placed on leave.

Vaccines

Pharmaceutical Technology

JULY 18, 2025

The concern of ocular toxicity was first highlighted in a document published ahead of the ODAC meeting that took place on 17 July. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Sign up for our daily news round-up!

Communication

Beckers Hospital Review

JULY 11, 2025

She joined the organization over 30 years ago and worked alongside providers and staff to drive improvements in patient care, culture and communication. Her calm, hands-on leadership during the Covid-19 pandemic earned widespread respect, guiding the hospital and community through uncertainty with clear communication and unwavering presence.

Hospitals

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

The update procedures should include how the AI-DSF modifications will be implemented and communicated to end users. Post-market surveillance plans and procedures (PMS) are a requirement under ISO 13485 which will be adopted into FDAs Quality Management System Regulation in 2026. Details of the PCCP will be publicly available (i.e.,

Documentation

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

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

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

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

Putting Patients First Blog

APRIL 14, 2023

The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. 10: External Data Submission Timing The NHC understands the tight timeline for the drug selection and price negotiation processes.

Drug Pricing

Putting Patients First Blog

JANUARY 10, 2024

Failure to Reconcile (FTR) Process: The NHC views the proposed changes to the FTR process positively as safeguarding consumers’ health coverage access, particularly for those with chronic conditions, by enhancing education, aligning with consumer protection principles, and ensuring clarity and accessibility in communication strategies.

Insurance Coverage and Processing

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.”

Packaging

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

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.

Communication

Putting Patients First Blog

FEBRUARY 11, 2025

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

Insurance Coverage and Processing