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1,251 Results
Type: News
Section: Industry News > Regulatory
Pharmaceuticals
Bayer Recalls 1.1M Alka-Seltzer Cartons for Packaging Issue
Bayer is retrieving more than a million cartons of Alka-Seltzer Original after complaints of holes or cracks in blister packs.
August 11, 2017
Alka-Seltzer Recalled / Image: Health Chemist
Pharmaceuticals
Biologics Behind Clinical Trial Supplies Market Growth
Increasing research in genetics and biotechnology, such as development of nanoparticle-based drug delivery systems and oncology therapies are key factors.
August 9, 2017
Increasing research in genetics and biotechnology, such as development of nanoparticle-based drug delivery systems and oncology therapies are key factors.
Pharmaceuticals
FDA Keeps Finding Viagra-Like Drugs in Coffee
FDA announces second voluntary recall of coffee distributed by Bestherbs Coffee LLC due to presence of a “Viagra-like drug.”
August 7, 2017
Stiff Bull Herbal Coffee Packaging / Image: FDA
Traceability/Serialization
HDA Launches its “Origin” Repository
HDA’s first product offers a central point to ease DSCSA-required master data exchange.
July 31, 2017
Data sharing through the Origin repository. Source: HDA
Pharmaceuticals
Securing the Supply Chain from Substandard and Falsified Drugs
FDA combines with international partners to create a new supply chain security toolkit that covers everything from raw materials to patient use.
July 21, 2017
FDA combines with international partners to create a new supply chain security toolkit that covers everything from raw materials to patient use. (Photo from FDA website.)
Pharmaceuticals
FDA Panel Unanimously Backs Two Cancer Biosimilars
The FDA’s Oncologic Drugs Advisory Committee recommends approval of biosimilar versions of Roche’s Avastin and Herceptin.
July 21, 2017
Avastin Packaging / Image: Roche
Pharmaceuticals
Microtags Provide On-Product Supply Chain Authentication
TruTag Wins 2017 North American Frost & Sullivan Award for edible microtags that can be used directly on pharmaceuticals.
July 12, 2017
TruTag Wins 2017 North American Frost & Sullivan Award for edible microtags that can be used directly on pharmaceuticals.
Supply Chain
Poll Reveals Lack of Confidence in Contract Service Orgs, Line Vendors
When asked about serialization preparation, challenges, and trade partner readiness, respondents had some less-than-stellar feedback. And which topic is one of the most valuable business benefits AND a major concern?
July 11, 2017
TraceLink Inc. recently held its annual NEXUS 17 conference in Barcelona.
Nutraceuticals/Dietary
Careful, Your Dietary Supplements Might Contain Steroids
Hardcore Formulations is recalling all lots of Ultra-Sten and D-Zine capsules due to the presence of anabolic steroids.
July 11, 2017
Dietary supplements contain anabolic steroids. / Image: King Features
Pharmaceuticals
FDA Issues One-Year Delay in DSCSA Product Identifier Enforcement
DSCSA law does not change, but enforcement is pushed back to Nov. 26, 2018, says agency in June 30 draft guidance.
July 5, 2017
FDA issued a June 30 draft guidance document that delays enforcement until Nov. 26, 2018 of DSCSA product identifiers at the package level. (Photo supplied by Adents).
Traceability/Serialization
What’s the Biggest Serialization Hurdle?
New research from SEA Vision and Zenith Technologies points to technology selection as a major challenge, with many others not far behind.
July 5, 2017
New research from SEA Vision and Zenith Technologies points to technology selection as a major challenge, with many others not far behind. Source: SEA Vision
Cannabis
Revamped Medical Marijuana Effort at the Federal Level?
Though many states have legalized medical marijuana, it’s still technically prohibited by the federal government. The CARERS Act for compassionate access and research has been reintroduced by a bipartisan group of senators, hoping to lift the federal ban in states with medical marijuana programs.
July 3, 2017
The CARERS Act for compassionate access and research has been reintroduced by a bipartisan group of senators,
Materials
Lisbon Summit Advances Serialization Supply Chain
Event helps forge partnerships as U.S. and European pharmaceutical CMOs, CPOs and 3PLs share strategies for serialization compliance and optimize post-implementation operations.
June 30, 2017
Event helps forge partnerships as U.S. and European pharmaceutical CMOs, CPOs and 3PLs share strategies for serialization compliance and optimize post-implementation operations.
Pharmaceuticals
Hospira Recalls Already-Scarce Sodium Bicarbonate
A lack of sterility assurance has led to the recall of several sodium bicarbonate products from Hospira, Inc.
June 28, 2017
Sodium Bicarbonate / Image: Pfizer
Pharmaceuticals
FDA Denies Pfizer’s Epogen Biosimilar… Again
The FDA has rejected Pfizer’s answer to Amgen’s blockbuster Epogen for the second time over fill-finish plant concerns.
June 27, 2017
Pfizer Sign / Image: FiercePharma
Adherence/Delivery
“Talking Pills” Could Cure the Opioid Epidemic
A New Jersey company has received a patent for a drug delivery system that can prevent death, theft, diversion, and counterfeiting.
June 22, 2017
Opioid Epidemic / Image: PediaBlog
Pharmaceuticals
Pig Brain Cells Could Be the Key to Treating Parkinson’s
Scientists have transplanted choroid plexus brain cells from pigs into Parkinson’s patients with promising results.
June 19, 2017
The adorable source of pig cells. / Image: Hobby Farms
Regulatory
Opioid Epidemic: FDA to Hold Public Meeting
Certain drug formulations may deter abuse, such as those that make crushing or liquefying for injection more difficult. FDA is seeking public comment to evaluate whether these methods will have their intended impact in the real world.
June 16, 2017
Certain drug formulations may deter abuse, such as those that make crushing or liquefying for injection more difficult.
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