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Search: Page 17

1,251 Results
Type: News
Section: Industry News > Regulatory
Pharmaceuticals
HDA, ValueCentric Announce API Certification for Origin
Origin is a source of GTIN reference data for the pharmaceutical industry. Adents represents the first partner to go through the certification process.
February 16, 2018
Origin is a source of GTIN reference data for the pharmaceutical industry. Adents represents the first partner to go through the certification process.
Regulatory
FDA's Draft Guidance on Label Highlights Section
The new guidance includes content and formatting information, and acknowledges where carton and container labels may differ from the Highlights. Comments are due March 20.
February 14, 2018
The new guidance includes content and formatting information, and acknowledges where carton and container labels may differ from the Highlights. Comments are due March 20.
Traceability/Serialization
Survey Reveals Serialization’s Potential Across Industries
New survey reports that companies across different industries consider the most important advantages of serialization to be protection against brand and product piracy and greater transparency in the logistics chain.
February 13, 2018
New survey reports that companies across different industries consider the most important advantages of serialization to be protection against brand and product piracy and greater transparency in the logistics chain.
Pharmaceuticals
FDA Labels Kratom Products ‘Opioids’
The FDA is heightening warning that kratom products present safety hazards and are prone to abuse.
February 13, 2018
Kratom / Image: Shutterstock
Medical Device/Packaging
Packaging Cliffs Notes: MDR’s Pertinent Updates
Live from PharmaPack Europe, Thierry Wagner lists the key MDR safety and performance requirements for sterile medical packaging and talks sterile barrier symbols.
February 7, 2018
Symbol proposal by the Sterile Barrier Association.
Pharmaceuticals
Carton Serialization Helps Idifarma Meet EU Falsified Medicines Directive
Spanish contract development and manufacturing organization (CDMO) Idifarma makes €200k investment to meet forthcoming EU serialization regulations.
February 7, 2018
Spanish contract development and manufacturing organization (CDMO) Idifarma makes €200k investment to meet forthcoming EU serialization regulations.
Pharmaceuticals
TraceLink Dismisses Litigation Claims Against HDA
TraceLink and HDA will work together with other industry players to propose interoperable standards and guidelines for pharmaceutical product master data, with the purpose of enabling compliance with the DSCSA.
February 6, 2018
TraceLink and HDA will work together with other industry players to propose interoperable standards and guidelines for pharmaceutical product master data, with the purpose of enabling compliance with the DSCSA.
Pharmaceuticals
FDA Adds Black Box Warning to Ocaliva
The liver disease medicine Ocaliva was erroneously dosed daily rather than weekly, putting patients at risk of serious liver injury.
February 5, 2018
Ocaliva / Image: Intercept
Pharmaceuticals
FDA Fast Tracks Zika Vaccine
The FDA granted ‘fast track’ status to TAK-426, Takeda’s Zika vaccine, in hopes of easing the international public health emergency.
February 2, 2018
Takeda / Image: Arnd Wiegmann
Pharmaceuticals
Can Unit-Dose Packaging Reduce Opioid Abuse?
Though not a mandate, FDA Commissioner Gottlieb recognizes that blister packaging could help alleviate addiction, abuse and overdosing of medications such as opioids and loperamide.
January 31, 2018
Though not a mandate, FDA Commissioner Gottlieb recognizes that blister packaging could help alleviate addiction, abuse and overdosing of medications such as opioids and loperamide.
Medical Device/Packaging
FDA Approves Japanese Lower-Body Exoskeleton
Cyberdyne’s Hybrid Assistive Limb is a robotic device that helps people with lower limb disabilities walk on their own.
January 30, 2018
Cyberdyne's HAL / Image: Cyberdyne
Regulatory
Police Get Involved in Botched Baby Milk Recall
A salmonella outbreak traced to Lactalis baby milk has led to a criminal investigation of five factories in France.
January 29, 2018
Recalled Lactalis Product / Image: Bob Edme
Pharmaceuticals
Careful, Your Laxative Might Not Be a Laxative
Magno-Humphries Laboratories recalled Senna Laxative tablets because the bottles were actually filled with pain relievers.
January 26, 2018
Senna Laxatives / Image: Pharma Packs
Pharmaceuticals
FDA OK’s Mayo Clinic’s Automated Stem Cell Producer
The FDA has granted the Mayo Clinic permission to use an automated bioreactor-based stem cell production platform at Jacksonville campus.
January 25, 2018
Stem Cell Producer / Image: Mayo Clinic
Pharmaceuticals
OPEN-SCS Group Addresses DSCSA Transaction Documentation
Lack of packaging standards could threaten serialization data integrity, says speaker during FDA meeting on drug distribution security.
January 25, 2018
Dirk Rodgers speaks at recent FDA public meeting on enhanced drug distribution security.
Cannabis
Industry Group Working on Standards for Cannabis Packaging and Labeling
The National Association of Cannabis Businesses is seeking to protect consumers and demonstrate responsibility in the eyes of regulators with standards. Comments on the draft standards are due by Feb. 21, 2018.
January 24, 2018
The National Association of Cannabis Businesses is seeking to protect consumers and demonstrate responsibility in the eyes of regulators with standards.
Pharmaceuticals
Gene Silencing is the New CRISPR
Rather than editing genes like CRISPR, gene silencing leaves the genome intact and deactivates RNA, keeping it from producing mutant proteins.
January 24, 2018
Gene Silencing / Image: Science Source
Traceability/Serialization
Antares Vision to Open Software Development Center in Ireland
New center in Galway will create more than 50 jobs in computer vision and artificial intelligence.
January 22, 2018
Massimo Bonardi, Managing & Technical Director for Antares Vision (left) and Emidio Zorzella, CEO of Antares Vision (right).
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