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1,251 Results
Type: News
Section: Industry News > Regulatory
Pharmaceuticals
Manufacturers Encounter Challenges Implementing Serialization in Developing Countries
According to a PMMI Business Intelligence report, pharmaceutical companies and manufacturers are struggling to establish global serialization standards.
June 29, 2018
Serialization Implementation
Pharmaceuticals
FDA Approves First Marijuana-Derived Drug
Epidiolex is the first FDA-approved drug derived from marijuana after an advisory committee unanimously recommended approval back in April.
June 27, 2018
FDA x CBC
Regulatory
Synthetic Blood Buys Patients More Time
Two scientists have each developed their own synthetic blood technologies that aim to keep patients alive on their way to the hospital.
June 20, 2018
Synthetic Blood
Pharmaceuticals
Family Behind OxyContin Maker Targeted in Opioid Lawsuit
The state of Massachusetts is suing the Sackler family, owners of Purdue Pharma, for spawning America’s opioid crisis.
June 19, 2018
OxyContin / Image: George Frey/Reuters
Traceability/Serialization
Track-and-Trace Market Predicted to Soar Through 2025
DSCSA’s Nov. 26, 2018 deadline for unit-level product identifiers is fast-approaching, but serialization and track and trace will remain relevant for years to come.
June 13, 2018
DSCSA’s Nov. 26, 2018 deadline for unit-level product identifiers is fast-approaching, but serialization and track and trace will remain relevant for years to come.
Pharmaceuticals
Nasal Spray Recalled After Packaging Found to Contain Glass Particles
Apotex Corp. is recalling one lot of nasal spray due to the presence of small glass particles that could affect the functionality of the pump.
June 8, 2018
Recalled Product / Image: Apotex
Pharmaceuticals
Packaging Error Could Lead to Pregnancy
Allergan’s Taytulla birth control capsules have been recalled due to a packaging error that could cause unintentional pregnancy.
June 4, 2018
Packaging Mix-Up / Image: Allergan
Traceability/Serialization
Six Months to DSCSA Enforcement Date
As the enforcement date for unit-level product identifiers nears, challenges lie ahead for manufacturers and the industry as a whole.
May 25, 2018
As the enforcement date for unit-level product identifiers is approaching in six months, challenges lie ahead for manufacturers and the industry as a whole.
Medical Device/Packaging
100,000 Women Sue Over Gynecological Mesh
A surgical device that’s implanted in more than two million American women causes extreme pain and injury, leading to thousands of lawsuits.
May 21, 2018
Gynecological Mesh / Image: CBS
Pharmaceuticals
FDA’s Gottlieb Comments on Trump Administration’s Plan to Lower Drug Prices
Commissioner Scott Gottlieb, MD, points to agency’s Drug Competition Action Plan and generic drug review process among its efforts ‘to put American patients first.’
May 11, 2018
Commissioner Scott Gottlieb, MD, points to agency’s Drug Competition Action Plan and generic drug review process among its efforts ‘to put American patients first.’
Traceability/Serialization
FDA: Guidance on DSCSA Waivers
New eight-page draft guidance helps trading partners understand the process for requesting waivers, exceptions and exemptions from DSCSA product identifier requirements.
May 9, 2018
New eight-page draft guidance helps trading partners understand the process for requesting waivers, exceptions and exemptions from DSCSA product identifier requirements.
Regulatory
FDA Cracks Down on E-Liquids with Packaging that Resembles Children’s Foods
The FDA is going after companies that make and sell e-liquids used in e-cigs with labeling aimed at children.
May 4, 2018
Nicotine Products That Resemble Children's Foods / Image: FDA
Medical Device/Packaging
FDA Reclassifies Sharps Needle Destruction Device
Agency believes final order will decrease regulatory burden on manufacturers as they will no longer be required to submit a premarket approval application (PMA), but can instead submit a less-burdensome premarket notification (510(k)) before marketing this type of device
May 3, 2018
Agency believes final order will decrease regulatory burden on manufacturers as they will no longer be required to submit a premarket approval application (PMA), but can instead submit a less-burdensome premarket notification (510(k)) before marketing this type of device. Shown here is a sharps collection container, not a needle destruction device.
Pharmaceuticals
Issues Arise from Noncompliant Rx Forms
The DOJ has identified four printers that continue to make noncompliant forms, preventing patients from getting prescriptions filled.
May 3, 2018
California Dental Association / Image: CPD
Medical Device/Packaging
FDA Approves Transition Contact Lenses
After 10 year of development, the FDA has approved Johnson & Johnson’s contact lenses that darken in sunlight.
April 26, 2018
Transition Contact Lenses
Pharmaceuticals
CDER Focuses on Drug Safety
Janet Woodcock points to annual ‘Drug Safety Priorities 2017’ report on CDER initiatives, and its efforts to evaluate evolving technologies to protect the public.
April 23, 2018
CDER's Drug Safety Priorities 2017 report.
Medical Device/Packaging
Approved: Catheters Coated With Bacteria Resistant Material
A team at the Schools of Pharmacy and Life Sciences discovered bacteria resistant materials in 2012 that now has a practical application.
April 20, 2018
Catheters / Image: Evidently Cochrane
Cannabis
First Cannabis-Derived Drug Nears FDA Approval
An advisory panel to the FDA votes in favor of approval of GW Pharma’s Epidiolex. The seizure drug would be the first FDA-approved use of cannabidiol (CBD).
April 19, 2018
An advisory panel to the FDA votes in favor of approval of GW Pharma’s Epidiolex. The seizure drug would be the first FDA-approved use of cannabidiol (CBD).
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