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RPM Cybersecurity 2026: FDA 524B Mandates & SBOM Compliance

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The RPM Cybersecurity Shift: Navigating New FDA Mandates and Software Supply Chain Transparency in 2026 A Senior Cybersecurity Architect's Field Guide — Because "We Think We're Covered" Is No Longer Good Enough May 2026  |  20-minute read  |  Written for C-Suite, Regulatory Affairs, and QA Leadership 📋 Table of Contents The Confidence Paradox: Why 90% Confidence Masks a 50% Coverage Gap The FDA Mandate Reality: Section 524B Is Not a Suggestion Anymore RPM Cybersecurity 2026: How CMS Expansion Created a New Attack Surface SBOM in 2026: From Compliance PDF to Quality System Backbone Comparison Table: Pre-2026 vs. The 2026 Mandatory Framework ISO 14971 as Connective Tissue: Risk Management Meets the Supply Chain Real-World Scenario: How a Mature SBOM Prevented a Class I Recall FDA Inspection Readiness: What Investigators Will Look For Under CP 7382.850 What You Need to Do Right Now: A 7-Poin...

Lilly sells R&D campus to Covance in the pioneering deal.

Lilly sells R&D campus to Covance in the pioneering deal.. Yesterday, Eli Lilly made a significant step toward outsourcing with the sale of a significant R&D site to contract research group Covance and the formation of new contracts with Quintiles and i3.  Lilly is adopting a road that is less usual in R&D but is already well-trodden in the pharmaceutical manufacturing industry. When faced with excess capacity, several pharmaceutical companies chose to sell off operations, frequently including legacy contracts, to management buyout teams or reputable contract manufacturers. The Lilly/Covance deal is one of the first large-scale examples of this type of facility sale in early-stage drug development – a function that until recently was jealously guarded within the walls of big pharma companies.  According to the terms of the agreement, Covance will offer jobs to 260 Lilly employees who work in non-Good Laboratory Practice (GLP) toxicology, in vivo pharmacology, quali...

Dr Reddy's in collaboration with SkyePharma on delivery system

Dr Reddy's in collaboration with SkyePharma on delivery system Using two of SkyePharma's unique drug delivery systems, the UK company SkyePharma has agreed to conduct a feasibility study on an unnamed product with Dr Reddy's Laboratories of India. The study's expenses will be covered by Dr. Reddy's, and SkyePharma will also get a "small" up-front payment, according to the two businesses. Full development activities would start later this year, they stated, if the feasibility study is successful.  With organizations like GlaxoSmithKline, Roche, Schiele, Novartis, AstraZeneca, Nitec, and Abbott in the past, SkyePharma has collaborated on the development of both licensed pharmaceuticals as well as drugs in development that use the oral, inhalation, and topical drug delivery technologies of the UK company.  The FDA recently requested a second clinical study to gather additional efficacy data on the bronchodilator/steroid combination found in SkyePharma's p...

Researchers target ocular drug delivery market

Researchers target ocular drug delivery market Researchers have developed a drug delivery device which attaches to the eye and could negate the need for repeat injections. The team from the University of Southern California has created a simple polymer device which is inserted under the conjunctiva and delivers a therapeutic to the affected area. In time the device could come to replace the intravitreal injections which patients suffering from glaucoma and related eye diseases currently have to be administered with.  Ellis Meng, researcher on the project, was keen to emphasise further refinements are in the pipeline. She said: " This prototype isn't optimally sized; it's our first go at proving the concept. We're now building a next-generation device ."  The one centimetre long prototype consists of a refillable reservoir sutured to the sclera which contains the therapeutic. Leading off this is a flexible tube which is inserted into the side of the eye and throug...

Competition intensifying for diabetes subjects; Acurian

Competition intensifying for diabetes subjects; Acurian Acurian, a company that specializes in patient recruiting, has reached a significant business milestone with the addition of more than 50 percent of the country's type 2 diabetes population to its database.  Approximately 8 million of the estimated 16 million diagnosed type 2 or adult-onset diabetes are already on the company's books. The business maintains a database of almost 40 million patients in total. According to Rick Malcolm, PhD, CEO of Acurian, "It should come as no surprise that diabetes is one of the most strong indications in our database. However, given the fierce rivalry for research participants in this therapeutic field, the fact that more than half of the nation's type 2 diabetics are present and open to learning about clinical trials is definitely important to note.  According to him, Acurian can assist trial sponsors in gaining access to huge numbers of diabetic patients so they can successfull...