The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. ...
Tags: Generic Drug, Medicine
Oticon Medical, a manufacturer of bone anchored hearing systems, has obtained 510(k) approval the US Food and Drug Administration (FDA) to market its Ponto Plus bone anchored sound processors in regular version (down to a hearing loss of ...
Tags: Oticon Medical, Ponto Plus Bone
Navidea Biopharmaceuticals has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for the approval to market and sale Lymphoseek Injection for sentinel lymph node (SLN) detection in patients ...
There is no evidence showing over-the-counter antibacterial soap products are any more effective at preventing illness than plain soap and water, officials say. Colleen Rogers, a lead microbiologist at the Food and Drug Administration, ...
Tags: 'antibacterial'Soap, FDA Rule
Ocera Therapeutics (Nasdaq:OCRX) today announced that it has entered into a Technology Transfer and License Agreement with the Roche Group, including the Research and Early Development arms of both Genentech and Roche, for rights to its ...
Tags: Ocera Therapeutics, Roche, Macrocyclic Template Chemistry
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. and partner, Banner Pharmacaps Inc. (a wholly-owned subsidiary of Patheon Inc.), have entered into a settlement and license agreement with Eisai Inc. ...
Tags: Mylan, Targretin Suit, Treatment of Cutaneous Manifestations
The U.S. Food and Drug Administration has announced that it will propose revised rule language and open another comment period on?two of the proposed rules affecting farmers under the Food Safety Modernization Act (FSMA). FDA plans to ...
Tags: Agriculture, Food
The medical devices industry, already one of the most heavily regulated industries in the U.S., is confronting yet another complex rule – Section 1502 of the Dodd-Frank Act, which requires SEC-listed companies to disclose the use of ...
Tags: Conflict Minerals Rule, Section 1502 of the Dodd-Frank Act
A true Tier-1 WCS must be equipped to handle 2D barcode and RFID data for individual unique SKU track and trace requirements.Multi-channel order fulfillment, referred to in the logistics industry as omni-channel fulfillment, is increasingly ...
EMD Serono, a subsidiary of Merck KGaA, has announced that Gonal-f RFF Redi-ject, a disposable pre-filled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f RFF, is now available in the US for ...
Tags: Health, Medicine, Redesigned Fertility Pen
Corgenix Medical, in collaboration with Randox Laboratories, has filed first 510(k) premarket notification with the US Food and Drug Administration (FDA) for the TxBCardio immunoturbidimetric assay. According to Corgenix Medical, ...
Hundreds of thousands of automated external defibrillators (AEDs) made by Philips Healthcare might not deliver a needed shock to the heart in an emergency, the U.S. Food and Drug Administration said in an updated warning. Latest ...
CSL Behring has announced that Kcentra (prothrombin complex concentrate [human]) has received the US Food and Drug Administration (FDA) approval for an expanded indication -- urgent reversal of acquired coagulation factor deficiency induced ...
Tags: CSL Behring, Medicine
PathoGenetix, Inc., a developer of an automated system for bacterial strain typing, and Marshfield Food Safety, LLC, a full service microbiology and chemistry contract testing laboratory, have signed an agreement to evaluate ...
Tags: Food Industry, automated system
The budget deal that received overwhelmingly support from the House on Thursday includes language that would repeal the 2.3% medical device excise tax. In addition, the deal would give FDA access to user fees paid by the device industry in ...
Tags: FDA, medical reform, budget deal, device tax