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Search: Page 15

1,251 Results
Type: News
Section: Industry News > Regulatory
Nutraceuticals/Dietary
FDA Warns Against Dietary Supplements with Too Much Caffeine
April 19, 2018
Caffeine Supplements / Image: Bulk Supplements
Medical Device/Packaging
FDA Modernizes Approach to Medical Device Safety and Innovation
New action plan focuses on five key areas, including timely postmarket mitigations, cybersecurity and taking a Total Product Life Cycle approach to device safety.
April 18, 2018
New action plan focuses on five key areas, including timely postmarket mitigations, cybersecurity and taking a Total Product Life Cycle approach to device safety.
Traceability/Serialization
New OIG Report Calls for FDA Education for Pharma Dispensers
In a review of 40 pharmaceutical dispensers, an OIG study shows that most received all drug product tracing details from their trading partners, but more work needs to be done.
April 13, 2018
In a review of 40 pharmaceutical dispensers, an OIG study shows that most received all drug product tracing details from their trading partners, but more work needs to be done.
Regulatory
FDA Finalizes Drug Development Process Guidance
Special Protocol Assessment Guidance for Industry aims to bring greater predictability and certainty in new medicine studies to support safety and efficacy.
April 13, 2018
Regulatory
FDA Says to Stay Away From Mexican Diaper Cream
A Mexican diaper cream sold at several chain stores has been recalled due to yeast, mold, and bacteria contamination.
April 12, 2018
Affected Diaper Cream / Image: Amazon
Medical Device/Packaging
FDA Offers Option for 510(k) Clearance
Abbreviated program aims to facilitate evolutionary medical devices to benefit patients. Agency seeks comment on the draft guidance by July 11.
April 11, 2018
Abbreviated program aims to facilitate evolutionary medical devices to benefit patients. Agency seeks comment on the draft guidance by July 11.
Supply Chain
New ASTM International Standard Supports Hazardous Materials Packaging
A new ASTM International standard helps with pressure testing certain containers that are used to transport hazardous materials.
April 11, 2018
A new ASTM International standard helps with pressure testing certain containers that are used to transport hazardous materials. This infographic describes the different types of ASTM standards. More than 12,000 standards provide assistance to companies across a wide range of industries and applications. (Source: ASTM International)
Regulatory
Bayer’s Packaging Innovation Challenge
The healthcare company is hosting the challenge June 5 at the Active & Intelligent Packaging Summit Americas in New Jersey.
April 10, 2018
Bayer’s Packaging Innovation Challenge
Nutraceuticals/Dietary
FDA Forces Unprecedented Mandatory Recall of Kratom Products
Triangle Pharmanaturals’ failure to comply with a voluntary recall led the FDA to hit them with a rare mandatory recall of all products.
April 4, 2018
Kratom Capsules / Image: Mary Esch
Cannabis
The Push to Reclassify Hemp Federally
Mitch McConnell will introduce legislation to legalize hemp and allow states to institute their own regulations.
March 28, 2018
Senate Majority Leader Mitch McConnell announced that he will soon file the Hemp Farming Act of 2018. PC: mcconnell.senate.gov
Pharmaceuticals
Ex Pharma CEO Gets Prison Time for Kickbacks
A former executive at Omaha’s Pharmaceutical Technologies Inc. will pay a hefty fine and serve time for agreeing to millions in illegal kickbacks to representatives.
March 28, 2018
Douglas M. Pick, former president and CEO of PTI / Image: Creighton University
Medical Device/Packaging
Blood Collection Tubes Recalled Due to Chemical Interference
Becton Dickinson is recalling blood collection tubes because a chemical in the rubber stopper interferes with diagnostic testing.
March 26, 2018
Recalled BD Vacutainer / Image: Amazon
Pharmaceuticals
FDA Statement Addresses Drug Compounding and Outsourcing Facilities
Commissioner Scott Gottlieb’s announcement takes a step forward in implementing DQSA and section 503B; directs agency to develop 503B bulks list.
March 23, 2018
Commissioner Scott Gottlieb’s announcement takes a step forward in implementing DQSA and section 503B; directs agency to develop 503B bulks list.
Pharmaceuticals
Report Cites Pharmaceutical and Healthcare as Fastest-Growing Anti-Counterfeit Segment
Manufacturers increasing their focus on brand protection to reduce counterfeiting of medicines and healthcare products.
March 22, 2018
Manufacturers increasing their focus on brand protection to reduce counterfeiting of medicines and healthcare products.
Medical Device/Packaging
Connecting to the Pros and Cons of Mobile Medical Devices
New Royal Academy of Engineering report recognizes that digital health could positively transform health care while acknowledging patient privacy concerns.
March 22, 2018
New Royal Academy of Engineering report recognizes that digital health could positively transform health care while acknowledging patient privacy concerns.
Regulatory
FDA Announces Mobile App
Agency says advancing mobile apps that inform people about their health and medical choices represents a significant public health opportunity and a high priority for the FDA.
March 22, 2018
Pharmaceuticals
Cash, Lap Dances, and Food are Decent Incentives to Prescribe Opioids
Five Manhattan doctors were bribed to over-prescribe a highly potent and addictive spray version of fentanyl.
March 22, 2018
Physician Bribery / Image: Fierce Healthcare
Pharmaceuticals
Good News: Male Birth Control Doesn’t Affect Sex Drive
Clinical trial results are in, and the male contraceptive pill is not only safe to use, it won’t harm your sex drive.
March 21, 2018
Male Birth Control / Image: Paul Grover
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