Wednesday, November 30, 2016

The Food and Drug Administration (FDA) announced an open period for applications for grants to support the development of new animal drugs intended for minor species or minor uses in major species (major species are horses, dogs, cats, cattle, pigs, turkeys and chickens).
Secondhand (and Third-hand) Smoke May Be Making Your Pet Sick
If you’re a smoker, you probably realize the dangers smoking may pose to your health. But have you ever thought about how the habit affects your pet?
According to Food and Drug Administration (FDA) veterinarian Carmela Stamper, the news is not good.
“Smoking’s not only harmful to people, it’s harmful to pets, too,” Stamper says. If 58 million non-smoking adults and children are exposed to tobacco smoke, imagine how many pets are exposed at the same time.

Monday, November 28, 2016

The FDA is confirming the effective date of December 1, 2016, for the direct final rule amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species.
The FDA is extending the comment period to continue seeking public input on establishing appropriately targeted durations of therapeutic use of medically important antimicrobial drugs in food-producing animals. The FDA is taking this action in response to requests for additional time to submit comments. The comment period will now close on March 13, 2017.

Friday, November 18, 2016

Trump’s brief medicines update sends tongues wagging at ‘FDA reform’ promise

Trump’s brief medicines update sends tongues wagging at ‘FDA reform’ promise

November 11, 2016 | By Ben Adams
As the Trump bump for biotech continues to reverberate after he became president-elect on Wednesday, biotech may now have more to celebrate as a new, but lightly detailed, healthcare update is being seen by some as a positive read-through for the industry.
A working group at the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) has finalized its report on proposed changes to improve the efficiency of approvals for the use of multiple new animals drugs in combination drug medicated feeds, while still protecting public health. These proposed changes are consistent with a performance goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter and are based on public comment. This report will be used in discussions concerning the reauthorization of the animal drug user fee program for five additional years through fiscal year 2023 (ADUFA IV).

Thursday, November 17, 2016

1 day ago - 2016 California Veterinary Medical Association. CompoundingResources · Pharmaceutical Information · Go Back ...

Monday, November 14, 2016

The U.S. Food and Drug Administration today announced the approval of Itrafungol (itraconazole oral solution), a new animal drug for treating dermatophytosis caused by Microsporum canis in cats. Commonly called ringworm, dermatophytosis is a fungal infection of the skin. Itrafungol works by selectively binding to certain fungal proteins, causing irreversible structural degeneration of the fungi.

Tuesday, November 1, 2016

The U.S. Food and Drug Administration (FDA) has issued a draft revision of Guidance for Industry (GFI) #170: Animal Drug User Fees and Fee Waivers and Reductions. This guidance describes the fees the agency is authorized to collect under the Animal Drug User Fee Act of 2003 (ADUFA), as amended, the information the FDA recommends sponsors submit in support of a request for a fee waiver or reduction, how to submit such a request, and the FDA’s process for reviewing these requests. This draft revision of the guidance clarifies the criteria for Barrier to Innovation waivers, clarifies the procedures for Small Business waivers, and makes additional clarifying changes.