Issues > Regulatory | Healthcare Packaging

FDA Permits Marketing for Test to Improve Diagnosis of Alzheimer’s Disease

The Lumipulse test is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations found in human cerebral spinal fluid.

the[PACK]out: Supply Chain - Navigating Disruptions

EXPERIENCE the[PACK]out: Created for industry professionals, by industry professionals.

5 ways to embrace sustainability in healthcare packaging

5 ways to embrace sustainability in healthcare packaging

Identify improvement opportunities at every stage of your packaging’s lifecycle. The time to act is now!

Cybersecurity in Medical Devices: FDA Announces New Draft Guidance

The new guidance deals with quality system considerations and the content of premarket submissions for members of the medical device industry, as well as Food and Drug Administration staff.

Speakers from left at TempPack: Mark Maurice, Sensitech; Eric Silberstein, eBiotech Consulting, LLC; Bryan Cardis, Eli Lilly and Company; Arif Rahman, MaxQ Research LLC

10 Temperature Monitor Qualification Considerations

From the 2022 ISTA Forum TempPack: Panelists discussed the latest on temperature recording device (TRD) qualification, including dry ice and LCD screens, probes that disconnect, and what to consider before selecting a shipper integrated with a TRD.

FDA Recommends Use of Duodenoscopes With Innovative Designs to Enhance Safety

The agency is providing new information supporting the transition to fully disposable duodenoscopes and those with disposable components, as well as new information on completed post-market surveillance studies.

5 ways to embrace sustainability in healthcare packaging

5 ways to embrace sustainability in healthcare packaging

Identify improvement opportunities at every stage of your packaging’s lifecycle. The time to act is now!

Heuft Spotter Ii Phs

Full Vial Inspection: Simply Complete!

Unit carries out optical and radiometric inspection and volumetric determination of O2 content in the headspace

Getty Images 1161368565

Future for Pharmaceutical Manufacturers Includes More Digitized Data Collection

While automation is driving physical changes to pharmaceutical production and packaging processes, another significant shift is occurring in the accumulation and use of data.

Regulation EU No 536/2014 on clinical trials will come many changes that will impact study startup processes and timelines, expiry labeling on primary and secondary packaging, and study administration methods such as direct-to-patient.

Part 1: Manage Challenges from the EU 536/2014 Clinical Trials Regulation

Plan ahead for study startup timelines, expiry labeling on primary packaging solutions, and study administration methods.

Pw 7643 Web Cargo

Tips for Exporting Goods in 2022

Live from Natural Products Expo West: An international trade expert discusses why you need to know your buyers, what you can ship to a sanctioned country, insurance for sea cargo, and more.

FDA Issues Voluntary Recalls Final Guidance

The guidance will help companies prepare to quickly and effectively remove violative products from the market, as the agency urges companies to be “recall ready” to protect public health.

Industry Reacts to FDA Draft Guidance on Injectable Products Inspection

Pharmaceutical companies and the International Society for Pharmaceutical Engineering want the FDA to align visible particle classifications and inspections with USP.

FDA Proposes Rule to Amend Medical Device CGMP Requirements

The proposed amendments to the CGMP requirements of the Quality System (QS) Regulation will align them more closely with the international consensus standard for devices.

Fda Chief Robert Califf

New FDA Chief Confirmed by Senate

Dr. Robert Califf narrowly secures position again on a 50-46 vote, despite concerns over his pharmaceutical industry ties.

GAO Makes Recommendations to Improve FDA Foreign Inspection Program

Drugs manufactured overseas for the U.S. market must meet the same requirements as those manufactured in the U.S., raising questions about the equivalence of foreign to domestic inspections.

FDA Proposes Rule for Wholesale Drug Distributors, Third-party Logistics Providers

If passed, the rule would allow only those licensed according to the proposed national standards to engage in transactions related to the sale and distribution of certain prescription drugs with other members of the supply chain.

FDA Publishes Draft Guidance on Reporting Certain Medical Device Shortages

The new guidance helps clarify how the agency interprets 506J notification requirements, including when and who should submit a notification and the information that should be included.

Safety in Aseptic Filling

FDA provides insight into common pitfalls found during inspections along with possible solutions.

FDA Releases Medical Devices Draft Guidance for Review

“The Transition Plan for Medical Devices Issued Emergency Use Authorizations During the Coronavirus Disease 2019 Public Health Emergency” guidance is now available for review.

Aseptic processing is one of the highest risk pharmaceutical operations, and thus requires a high level of control.

Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections

From personnel to facility design to process, FDA policy advisor provides an outline of what facilities can improve on.

Serialization Master Data 60a571e0dae99

Counting Down the Top 10 Articles of 2021 - #1: Serialization 101

Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #1, we’re going back to basics with an introductory look at serialization, required by pharma and medical device regulations to defend against counterfeiting.