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1,251 Results
Type: News
Section: Industry News > Regulatory
Medical Device/Packaging
FDA Loophole Lets Med Device Companies Hide Injuries
Analysis finds delays and loopholes in how and when medical device companies report adverse events to the FDA.
October 19, 2016
Baxter Colleague Drug Pump / Photo: Baxter
Pharmaceuticals
FDA Pauses Regeneron/Teva Painkiller Study
Opioid-alternative fasinumab gets halted during mid-stage trial due safety concerns.
October 18, 2016
Fasinumab study halted by FDA / Photo: FierceBiotech
Pharmaceuticals
Supply Chain Leaders to Gauge DSCSA Implementation Progress
Healthcare Distribution Alliance (formerly HDMA) to host seminar that includes distributors, manufacturers, pharmacists and third-party logistics providers.
October 13, 2016
Healthcare Distribution Alliance (formerly HDMA) to host seminar that includes distributors, manufacturers, pharmacists and third-party logistics providers.
Materials
Technological Innovations to Lift Drug-Device Market
New report predicts therapeutic benefits and regulatory process will drive greater acceptance of combination products through 2024.
October 12, 2016
New report predicts therapeutic benefits and regulatory process will drive greater acceptance of combination products through 2024.
Medical Device/Packaging
Baxter Micron Filter Recall
Potential for missing filter membrane prompts Class 1 recall of all unexpired lots.
October 12, 2016
Baxter 50 mm 0.2 Micron Filter / Photo: Baxter
Traceability/Serialization
sc cp test
October 6, 2016
Pharmaceuticals
Cannabis Derivative Inches Toward FDA Approval
New cannabidiol-based drug shows promising results in Phase 3 trial for treating Lennox-Gastaut syndrome.
October 6, 2016
Cannabis Plant / Photo: GW Pharmaceuticals
Materials
Tips for ACE: Importing Drugs Through U.S. Customs
U.S. Customs and Border Protection created the ACE system to provide a single window to interact, manage and oversee import and export data. Aiming to transition to the system by the end of 2016, the organization has already observed a 25% faster processing time among ACE submitted entries.
October 5, 2016
With ACE, data prompts will help filers to ensure the proper information is submitted. These prompts will also help the FDA speed entry decisions, as reviewers will not have to verify information manually in a separate database.
Regulatory
Are Poop Transplants the Key to Weight Loss?
Scientists determine diversity of bacteria living in feces is linked to body weight and risk of certain metabolic diseases.
October 4, 2016
Laurel's feces could've helped Hardy lose weight. Photo: www.bbc.com
Materials
Track and Trace Market Predicted to Soar
Brand protection, increasing packaging-related product recalls, and the need to ensure regulatory compliance to trigger track and trace market growth through 2021.
September 30, 2016
MarketsAndMarkets says brand protection, increasing packaging-related product recalls, and the need to ensure regulatory compliance to trigger track and trace market growth through 2021.
Pharmaceuticals
Examining the Science Behind Cargo Covers for Temperature-Sensitive CRT Pharmaceuticals
DuPont Protection Solutions’ Steve Brabbs to speak at PDA pharma logistics event in Amsterdam Oct. 11-12.
September 29, 2016
DuPont Protection Solutions’ Steve Brabbs to speak at PDA pharma logistics event in Amsterdam Oct. 11-12.
Pharmaceuticals
Wells Pharmacy Recalls Hundreds of Products
FDA prompts recall of over 600 Wells Pharmacy Network products due to “lack of sterility assurance.”
September 28, 2016
Wells Pharmacy Products / Photo: Wells Pharmacy
Pharmaceuticals
HHS Makes Clinical Trials Easily Accessible to Public
U.S. Department of Health and Human Services issues final rule to make clinical trial information more widely available to the public.
September 26, 2016
ClinicalTrials.gov interface
Traceability/Serialization
Rechon & Adents Team Up for Serialization
Drug developer and manufacturer Rechon partners with serialization expert for track & trace solution.
September 23, 2016
Rechon
Regulatory
LIVE FROM PDA/FDA: An Overview of FDA’s Expectations of Biosimilars
Similar biological medicinal products are not the same as small-molecule generics in terms of their complexity or the approval process, which evaluates residual uncertainty at each step.
September 14, 2016
Similar biological medicinal products are not the same as small-molecule generics in terms of their complexity or the approval process, which evaluates residual uncertainty at each step.
Materials
LIVE FROM PDA/FDA: Compliance to Quality: Part 2
Retired Amgen Chief Quality Officer discusses building a quality culture from the top.
September 14, 2016
Biosynthetic insulin, artificial heart transplants, and the Orphan Drug Act all exemplify progress in serving patients.
Pharmaceuticals
LIVE FROM PDA/FDA: Compliance to Quality: Part 1
CDER’s Office of Pharmaceutical Quality aims to establish a collaborative approach with manufacturers to encourage innovation and the adoption of new technologies.
September 14, 2016
CDER’s Office of Pharmaceutical Quality aims to establish a collaborative approach with manufacturers to encourage innovation and the adoption of new technologies.
Pharmaceuticals
LIVE FROM PDA/FDA: Regulated Biologics Offer Therapeutic Promise; Manufacturing Challenges
Many genetically modified cellular therapies are developed with relatively small safety and efficacy datasets from clinical trials. As a result, some are eligible for orphan designation, which allows for fast-tracking to market.
September 13, 2016
LIVE FROM PDA/FDA: Regulated Biologics Offer Therapeutic Promise; Manufacturing Challenges
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