FDA News

FDA Approvals - Emergent BioSolutions Receives FDA Approval for BioThrax Administered Intramuscularly in

Fri, 18 May 2012 05:05:10 +0000

Emergent BioSolutions Receives FDA Approval for BioThrax Administered Intramuscularly in a Three-Dose Primary Series ...
Emergent BioSolutions Inc. announced today that the U.S. Food and Drug Administration has approved its supplemental Biologics License Application to change the administration schedule of BioThrax to a three-dose primary series of intramuscular injections at 0, 1, and 6 months.

Fighting Fat: FDA Panel OKs Arena Diet Pill
In a move that may herald a new era in fighting fat, an FDA advisory voted 18-to-4 to recommend the agency approve the Arena Pharmaceutical diet pill, which is known as Lorqess. This marks the second time in three months that an FDA panel has decided the benefits of reducing the growing American waist line outweigh the various risks that have delayed this latest round of fat-fighting drugs from ...

FDA approves Votrient for advanced soft tissue sarcoma The U.S.

Fri, 18 May 2012 00:30:07 +0000

FDA approves Votrient for advanced soft tissue sarcoma
The U.S. Food and Drug Administration today approved Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues.

FDA proposal aims to help reduce unnecessary radiation exposure for

Thu, 17 May 2012 23:30:07 +0000

FDA proposal aims to help reduce unnecessary radiation exposure for children
Today, the U.S. Food and Drug Administration announced that it is seeking public comment on a proposal encouraging manufacturers to consider the safety of children in the design of new X-ray imaging devices. In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.

2012 BIO International Convention to Highlight the FDA and Regulatory

Thu, 17 May 2012 21:05:07 +0000

2012 BIO International Convention to Highlight the FDA and Regulatory Environment
The U.S. regulatory environment strongly impacts innovation and the development of new drugs and biologics. With this in mind, the Achieving Regulatory Approval and Compliance educational track at the 2012 BIO International Convention will tackle the most pressing regulatory issues facing the industry, specifically the reauthorization of the Prescription Drug User Fee Act , implementation of the ...

FDA Approvals - Study: US clears drugs faster than Europe, CanadaResearchers say the

Thu, 17 May 2012 07:10:04 +0000

Study: US clears drugs faster than Europe, Canada
Researchers say the U.S. approved more new medicines in less time than Europe and Canada in the last decade, challenging long-standing criticisms that the Food and Drug Administration lags behind its peers in clearing important new drugs.

FDA expands use for FilmArray Respiratory Panel The U.S. Food

Thu, 17 May 2012 01:35:04 +0000

FDA expands use for FilmArray Respiratory Panel
The U.S. Food and Drug Administration today expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample.

Implants may help prevent repeat teen pregnanciesNEW YORK (Reuters Health)

Thu, 17 May 2012 01:30:09 +0000

Implants may help prevent repeat teen pregnancies
NEW YORK (Reuters Health) - Up to half of teens and young women who give birth are pregnant again within a year -- but a new study suggests giving new moms a contraceptive implant before they leave the hospital the first time around can help prevent those repeat pregnancies. Contraceptive implants are placed under the skin, typically in a woman's upper arm, and slowly release hormones. In the U ...

Birth control: Which is best for new moms?
Sure, becoming a mom is pretty amazing. And while doing the deed might be the furthest thing from your mind at the moment , we promise you'll want to have sex again someday.

CDC report: More teen girls use best birth control
More teen girls now use the best kinds of birth control, a new government study says.

Breast Companion Software System The Breast Companion Software System is

Thu, 17 May 2012 01:00:08 +0000

Breast Companion Software System
The Breast Companion Software System is a computer-aided report-generating system intended to improve the ACR BI-RADS (American College of Radiology, Breast Imaging Reporting and Data System) assessment of ultrasound images of lesions of the... (Approved: 2/10/2012)

Nestl Purina Voluntarily Recalls Single Lot of Therapeutic Canned Cat

Thu, 17 May 2012 00:40:05 +0000

Nestl Purina Voluntarily Recalls Single Lot of Therapeutic Canned Cat Food Due to A Low Level of Thiamine (Vitamin B1)
Nestl Purina PetCare (NPP) is voluntarily recalling one specific lot of its Purina Veterinary Diets OM Overweight Management canned cat food, available through veterinarians in the U.S. and Canada. This precautionary measure is being taken in response to one consumer complaint received by FDA.

Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml
Franck s lab recently had a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and on March 29, 2011 instituted a recall. The recall involved five physicians and eight prescriptions.

Cleveland Beansprouts Co. of Cleveland, OH is recalling all alfalfa sprouts because they may be contaminated with Listeria monocytogenes
Cleveland Beansprouts Co. of Cleveland, OH is recalling all alfalfa sprouts because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals with weakened immune systems. Although healthy individuals may suffer only short term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

FDA Approvals - FDA Approves BIOTRONIK Next Generation ICDs and CRT-DsBIOTRONIK, a leading

Wed, 16 May 2012 09:50:09 +0000

FDA Approves BIOTRONIK Next Generation ICDs and CRT-Ds
BIOTRONIK, a leading manufacturer of innovative medical technology, has received FDA approval of its new Lumax 740 implantable cardioverter defibrillators and cardiac resynchronization therapy devices .

BioElectronics Issues Letter to Shareholders
FREDERICK, Md., May 4, 2012 /PRNewswire/ -- BioElectronics Corporation. (OTC-PINK: BIEL), the maker of disposable, inexpensive drug-free topical pain and healing devices, today issued a letter to its shareholders. ...

Genzyme Announces Regulatory Approvals of Expanded Waterford, Ireland Manufacturing Plant
Genzyme, a Sanofi company , announced today that the Food and Drug Administration and the European Medicines Agency have approved a second

FDA proposal aims to help reduce unnecessary radiation exposure for

Wed, 16 May 2012 00:25:31 +0000

FDA approves imaging drug Amyvid Estimates brain amyloid plaque content

Tue, 15 May 2012 23:25:02 +0000

FDA approves imaging drug Amyvid
Estimates brain amyloid plaque content in patients with cognitive decline

Website claims and GMP violations continue to dominate FDA warning

Tue, 15 May 2012 21:05:06 +0000

Website claims and GMP violations continue to dominate FDA warning letters
Maryland-based From Fatigued to Fantastic, LLC also received a warning letter for language used on the company s website http://www.endfatigue.com relating to products promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)].

FDA Approvals - BioElectronics Issues Letter to ShareholdersFREDERICK, Md., May 4, 2012 /PRNewswire/

Tue, 15 May 2012 10:50:14 +0000

BioElectronics Issues Letter to Shareholders
FREDERICK, Md., May 4, 2012 /PRNewswire/ -- BioElectronics Corporation. (OTC-PINK: BIEL), the maker of disposable, inexpensive drug-free topical pain and healing devices, today issued a letter to its shareholders. ...

CyberSafe Announces Support for FDA 21 CFR Part 11 Compliance
ORLANDO, Fla., May 14, 2012 /PRNewswire-iReach/ -- CyberSafe , a leading security software vendor and SAP partner, today announced that the latest version of its TrustBroker Secure Client product delivers ...

FDA Approvals - BioElectronics Issues Letter to ShareholdersFREDERICK, Md., May 4, 2012 /PRNewswire/

Mon, 14 May 2012 11:45:05 +0000