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1,251 Results
Type: News
Section: Industry News > Regulatory
Pharmaceuticals
Medicines as Weapons?
Packaging continues to help improve patient outcomes, yet the lives of U.S. patients are seemingly at the mercy of other countries that manufacture APIs and drugs.
August 24, 2018
Packaging continues to help improve patient outcomes, yet the lives of U.S. patients are seemingly at the mercy of other countries that manufacture APIs and drugs.
Pharmaceuticals
China Vaccine Scandal Leads to Recall
China’s $122 billion pharmaceutical industry loses credibility with the handling of a defective vaccine that made it overseas.
August 23, 2018
Vaccine Recall / Image: BBC
Pharmaceuticals
Teva’s Generic EpiPen First to Gain FDA Approval
Approval of the first generic competitor to Mylan’s EpiPen will spark downward pressure on the high-scrutinized price of the original.
August 22, 2018
EpiPen / Image: Getty Images
Regulatory
FDA Inspector Finds Spiders in Packaging Area
A Canadian API maker received a warning letter from the FDA after an inspector found spiders in their packaging area.
August 17, 2018
FDA / Image: FiercePharma
Regulatory
Lab-Grown Lungs Successfully Transplanted into Pigs
Researchers from University of Texas are one step closer to lab-grown lungs for humans with breakthrough pig transplants.
August 10, 2018
Lab-Grown Lungs / Image: iStock
Cannabis
California’s Cannabis Update: Beverages, Testing and More
The state of California experiences some pains this summer as the industry and regulations continue to evolve.
August 3, 2018
The state of California experiences some pains this summer as the industry and regulations continue to evolve.
Regulatory
J&J to Pay Record Amount in Talcum Powder Suit
A Missouri jury ordered Johnson & Johnson to pay out billions to women claiming their talc-based products contained asbestos and caused cancer.
July 27, 2018
J&J Baby Powder / Image: Healthline
Cannabis
FDA Warns of Contaminated Illegal Synthetic Marijuana
FDA has become aware of severe illnesses and deaths linked to contaminated synthetic marijuana products that could affect the U.S. blood supply.
July 26, 2018
FDA Warns of Contaminated Illegal Synthetic Marijuana
Pharmaceuticals
FDA Looks to End Patent Games to Lower Drug Prices
FDA Commissioner Scott Gottlieb has a plan to boost the biosimilar market and drive prices down by putting an end to patent “gaming.”
July 24, 2018
FDA Commissioner Gottlieb / Image: Undark
Supply Chain
Drug Importation in Times of Need
The HHS announced a work group to evaluate policies for importing certain drugs in short supply domestically. But one industry group has supply chain security concerns.
July 23, 2018
The HHS announced a work group to evaluate policies for importing certain drugs in short supply domestically. But one industry group has supple chain security concerns.
Pharmaceuticals
Pharma Company Blocks Nevada Execution
A New-Jersey based pharmaceutical company successfully prevented its drugs from being used in a Nevada execution.
July 20, 2018
Court Hearing / Image: CNBC
Regulatory
Innovations Helping to Grow the Clinical Trial Packaging Market
Due to rising number of discoveries of new drugs in research laboratories around the world, the global clinical trial packaging market is receiving a considerable lift, with the bottle segment leading the way.
July 19, 2018
Due to rising number of discoveries of new drugs in research laboratories around the world, the global clinical trial packaging market is receiving a considerable lift, with the bottle segment leading the way.
Pharmaceuticals
Novartis and Sandoz Recall Non-Compliant Blister Packs
The prescription drugs were not in child resistant packaging, which put them in violation of the Poison Prevention Packaging Act.
July 19, 2018
Recalled Packaging
Regulatory
CPSC Seeks Comment on Improving Recall Effectiveness
The Consumer Product Safety Commission is soliciting info on recall marketing, challenges, technologies, security and more. Comments are due by Sep 5, 2018.
July 18, 2018
The Consumer Product Safety Commission is soliciting info on recall marketing, challenges, technologies, security and more. Comments are due by Sep 5, 2018.
Regulatory
Aseptic Processing Woes for CMO in China
The producer of sterile injectables and APIs was hit with an FDA warning letter, citing issues with aseptic processing and data integrity.
July 12, 2018
The producer of sterile injectables and APIs was hit with an FDA warning letter, citing issues with aseptic processing and data integrity.
Regulatory
FDA Issues Draft Guidance on Labeling Rx and Biologics Products
Agency takes steps to encourage more informative labeling on prescription drug and biological products’ indications and usage.
July 6, 2018
Agency takes steps to encourage more informative labeling on prescription drug and biological products’ indications and usage.
Pharmaceuticals
$1.7M Chinese Fentanyl Shipment Intercepted in Philadelphia
Federal authorities seized 110 pounds of fentanyl packed into barrels of iron oxide at the Area Port of Philadelphia.
July 4, 2018
Fentanyl Seizure / Image: Fox 10
Traceability/Serialization
Report Projects Dynamic Track-and-Trace Market Growth
Should anyone think the serialization market might slow down once the Nov. 26, 2018 enforcement deadline to provide unit-level product identifiers on drug packages passes, it may be time to reconsider.
July 2, 2018
A new “track-and-trace solutions market” report from ReportsnReports predicts the track-and-trace solutions market will reach $3.93 billion by 2023, up from $1.65 billion in 2018. That represents a dynamic 18.9% Compound Annual Growth Rate.
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