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Search: Page 18

1,251 Results
Type: News
Section: Industry News > Regulatory
Regulatory
FDA Sets Compounding Policy Priorities Plan
Agency lays out 2018 plan to preserve legitimate pharmacy practices and protect patients; FDA also issues guidances for “essentially a copy” provisions and biologics products.
January 19, 2018
Agency lays out 2018 plan to preserve legitimate pharmacy practices and protect patients; FDA also issues guidances for “essentially a copy” provisions and biologics products.
Pharmaceuticals
FDA Requires Stricter Labeling for Opioid Cough Medicine
The FDA wants labeling changes for prescription cough and cold medicines that contain codeine or hydrocodone.
January 16, 2018
Codeine Cough Syrup / Image: Alpharma
Regulatory
FDA: UDI Compliance Dates
The “immediately-in-effect” guidance document lays out policy on compliance dates for class I and unclassified Devices.
January 12, 2018
The “immediately-in-effect” guidance document lays out policy on compliance dates for class I and unclassified Devices.
Pharmaceuticals
Recall Alert: Glass Particulate Found in Vials
AuroMedics Pharma is recalling Ampicillin and Sulbactam single-dose vials due to presence of glass particulate.
January 9, 2018
Ampicillin and Sulbactam / Image: AuroMedics
Pharmaceuticals
2017 U.S. Drug Approvals Double Over Last Year
The U.S. approved 46 novel medicines in 2017, the most since 1996. Figures in the EU also rose.
January 5, 2018
FDA Commissioner Gottlieb / Image: Reuters / Aaron P. Bernstein
Pharmaceuticals
FDA Approves First Gene Therapy for Hereditary Disease
The FDA has approved Luxturna, a gene therapy that treats patients with an inherited form of vision loss.
December 29, 2017
Luxturna / Image: Spark Therapeutics
Pharmaceuticals
Male Birth Control Gel Enters Trials
After a decade of research, a new contraceptive that you ‘rub on like a lotion’ will be tested on men.
December 28, 2017
Male Contraception / Image: Junior
Pharmaceuticals
FDA Says Not to Snort Chocolate Powder
The FDA posted a warning letter to Legal Lean Syrup and Coco Loko for promoting products as alternatives to street drugs.
December 22, 2017
Coco Loko / Image: LegalLeanStore.com
Regulatory
CDC’s Word Ban Includes ‘Transgender,’ ‘Fetus,’ & ‘Diversity’
The Trump administration has ordered the Centers for Disease Control and Prevention to stop using seven banned words.
December 20, 2017
CDC Sign / Image: David Goldman/AP
Pharmaceuticals
Vets Want Medical Marijuana for Pets
Veterinarians are pushing the FDA to allow research on the use of medicinal marijuana to treat animals.
December 19, 2017
Canine Cannabis / Image: Cannasos
Regulatory
FDA Issues Promotional Labeling Guidance
Agency takes new steps to help ensure clear presentation of health information in prescription drug promotion in an ongoing effort to protect consumer health.
December 11, 2017
Medical Device/Packaging
FDA Approves Screening Test for Cancer Gene
The FDA has approved the FoundationOne CDx, a first-of-a-kind test that seeks mutations in hundreds of cancer genes help narrow causes for tumors.
December 7, 2017
Tumor Profiling / Image: AP Photo/Gregory Bull
Medical Device/Packaging
FDA Clears First Med Device for Apple Watch
AliveCor’s KardiaBand uses Apple Watch’s heart rate technology and an attached sensor to give EKG readings.
December 6, 2017
KardiaBand / Image: AliveCor
Pharmaceuticals
Merck’s Ebola Vaccine Won’t See Approval in 2017
With the Ebola epidemic that’s killed 11,000 people looming, Merck & Co. will miss filing its vaccine for FDA approval this year.
December 1, 2017
Merck / Image: FiercePharma
Regulatory
FDA Updates 21st Century Cures Act Implementation
FDA Commissioner Scott Gottlieb provides testimony before the House Committee on Energy and Commerce on treatment advances and accelerated drug approvals.
November 30, 2017
FDA Commissioner Scott Gottlieb, MD, spoke about the Cures Act, citing progress on cancer drug approvals.
Medical Device/Packaging
New Robot Can Fix a Broken Heart
A new device cradles the heart and uses a probe to precisely manipulate a particular heart chamber to function properly.
November 29, 2017
Heart Device / Image: Payne
Medical Device/Packaging
Kevlar is the New Cartilage Replacement
Researchers at University of Michigan have developed “Kevlartilage,” a Kevlar-based hydrogel that could replace current synthetic alternatives.
November 28, 2017
Kevlar-Based Cartilage / Image: Digital Trends
Pharmaceuticals
Recipharm Equips Three More Facilities for U.S. Serialization
With today’s DSCSA deadline, CDMO Recipharm now has nine locations able to supply serialized products to the U.S.
November 27, 2017
With Nov. 27, 2017's DSCSA deadline, CDMO Recipharm now has nine locations able to supply serialized products to the U.S. Shown here is product labeling on a Recipharm packaging line.
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