Social Media Ideas for Fda Distributed Manufacturing

FDA Issues Proposal to Streamline Registration for Advanced Distributed Manufacturers

Distributed manufacturing establishments operate a hub-and-spoke model, with a central quality oversight hub and multiple equivalent manufacturing units at different locations. Reg...

FDA Proposes Distributed Manufacturing Registration Pathway and Aligns Foreign Establishment Registration and Listing Re...

The U.S. Food and Drug Administration (“FDA”) issued a proposed rule to update drug establishment registration and listing requirements for distributed manufacturing (“DM”) and cer...

FDA Seeks Public Feedback on Regulatory Approach for Generative AI-Enabled Medical Devices

<![CDATA[AI at the FDA: Efficiency, Oversight, and Open Questions]]>

<![CDATA[What FDA's Peptide Decision Means for the Industry]]>

CMS, FDA Propose RAPID Pathway for Medicare Coverage of Certain Medical Devices

Key Takeaways The proposed RAPID pathway would create a new voluntary CMS/FDA process for certain innovative medical devices, with the stated goals of expediting Medicare coverage...

Following Infant Formula Incidents, FDA Urges Manufacturers to Implement Stronger, Substantive Supplier Oversight

The letter to industry was issued in response to the botulism outbreaks linked to Nara Organics and ByHeart formulas, which identified Clostridia in the whole milk powder ingredien...

FDA to Centralize Administrative Functions, Generalize Inspectors

The notice formalizes proposed reorganization plans that surfaced in April 2025 amid the federal government-wide RIFs and the mass overhaul of HHS that occurred shortly after Presi...

FDA Turns the Spotlight on Regulatory Science: What Medical Device Developers Need to Know

By Jennifer D. Newberger —

Regulating a Moving Target – FDA Seeks Comments on Possible Framework for Regulation of GenAI

By Adrienne R. Lenz, Principal Medical Device Regulation Expert —

Regulatory Demands for More Process Control Data Fueling Innovation

Advances in technology are making it easier for biopharma companies to embrace continuous manufacturing. However, they are also changing what regulators expect from drug firms in t...

U.S. FDA Leadership from Three Centers and OII Headline the Center Office Updates Session of the 2026 PDA/FDA Joint Regu...

PDA announced today that senior leaders from the FDA's centers for drugs, biologics and veterinary medicine as well as the Office of Inspections and Investigations will participate...

Made Scientific announces MOU with NurExone for U.S. manufacturing and commercial supply partnership

NurExone Biologic Inc., a Frankfurt, Germany-based biotechnology company developing exosome-based regenerative therapies, said Aug. 13 that it and its wholly owned U.S. subsidiary,...

FDA Continues Shift of Inspections to States and Development of AI Tools

FDA Deputy Commissioner for Food Donald Prater recently explained that FDA is focusing on projects to use artificial intelligence (AI) and shift inspections to states, along with r...

ITM neuroendocrine tumor drug spurned by FDA over manufacturing qualms

The FDA has denied ITM Isotopes Technologies’ lead pipeline candidate for a rare group of tumors due to qualms over the drug’s manufacturing.

<![CDATA[Pharmaceutical Executive Daily: FDA Grants Traditional Approval to Novartis's Fabhalta]]>

<![CDATA[What Moments in FDA’s Review Process Should Patients and Providers be Watching Closely?]]>

<![CDATA[Why FDA is Sending an Increased Number of Drug Warning Letters]]>

A Sensor for Every Symptom: FDA Puts $1.1 Million Behind Digital Health in Drug Trials

By Mary Bass & Jennifer D. Newberger —

The FDA just picked its first company to sell an unauthorised device to Medicare patients

The US Food and Drug Administration named Dexcom as the first manufacturer selected for its Technology-Enabled Meaningful Patient Outcomes pilot on Tuesday. The programme, known as...

<![CDATA[FDA Grants Emergency Use Authorization for Seegene’s Multiplex PCR Assay ]]>

<![CDATA[The Significance of FDA’s First Warning Letter for Inappropriate Use of AI]]>

<![CDATA[Why Integrated GMP Operating Models Are Reshaping Outsourced Manufacturing]]>

FDA Eases Approval Path for Certain Cancer Companion Diagnostic Tests

The U.S. Food and Drug Administration has issued a final order moving certain laboratory tests used to help guide treatment with approved cancer drugs from...