Former CT Physician Pays $300K To Settle False Claims Act Allegations Zak Failla 10/01/2019 5:00 a.m.

https://dailyvoice.com/connecticut/fairfield/news/former-ct-physician-pays-300k-to-settle-false-claims-act-allegations/776538/

Notice on the Enforcement of USP Compounding Chapters for ...

https://www.pharmacy.ohio.gov › Documents › Pubs › Special › Notice on...

4 days ago - T: (614) 466.4143 | F: (614) 752.4836 | contact@pharmacy.ohio.gov | www.pharmacy.ohio.gov. Notice on the Enforcement of USP Compounding Chapters for.

Are Compounding Pharmacies Safe? 'Last Week Tonight ...

https://www.romper.com › are-compounding-pharmacies-safe-last-week-to...

7 hours ago - In a stomach-turning report on the 7500 compounding pharmacies operating in the United States, John Oliver revealed some truly harrowing statistics that left ...

(PR) Endo Announces Successful Culmination of Litigation ...

https://www.barrons.com › articles › PR-CO-20190930-905200

15 hours ago - That policy relied on "enforcement discretion" to allow bulk compounding of vasopressin, the active ingredient in Vasostrict(R) , which is manufactured by Endo's ..

Endo drops FDA lawsuit over compounding - The Pharma Letter

https://www.thepharmaletter.com › article › endo-drops-fda-lawsuit-over-c...

8 hours ago - The company had initially sued the FDA in October 2017, challenging its interim policy authorizing the bulk compounding of drugs, including Endo's antidiuretic 

John Oliver takes on compounding pharmacies - The Guardian

https://www.theguardian.com › tv-and-radio › sep › john-oliver-takes-on-c...

11 hours ago - 'Wild west of the drug industry': John Oliver takes on compounding pharmacies. The Last Week Tonight host looks into the largely unregulated, and therefore ...

John Oliver, Kristen Bell and Jimmy Kimmel Talk Pharmacies ...

https://time.com › Newsfeed › Television

18 hours ago - Compounding pharmacies have messed with the wrong celebrities. On Sunday's episode of Last Week Tonight, John Oliver and a star-studded guest list hit ...

John Oliver Highlights Dangers of Compounding Pharmacies ...

https://www.rollingstone.com › tv-news › john-oliver-method-man-michae...

11 hours ago - Before the cameos, Oliver defined the compounding process and dove into the hazards that have made headlines. Compounding pharmacies, he explained, ...

Last Week Tonight: John Oliver on compounding pharmacies ...

https://slate.com › culture › 2019/09 › last-week-tonight-john-oliver-compo...

12 hours ago - Uploaded by LastWeekTonight

Compounding pharmacies do the important work of tailoring medications to the needs of a particular patient ...

John Oliver taps Jimmy Kimmel, Kristen Bell for compounding ...

https://ew.com › TV

14 hours ago - John Oliver assembled a team of celebrities, including Jimmy Kimmel and Kristen Bell, to take on “the Wild West of the drug industry,” as he called compounding ...

John Oliver and a delightful melange of celebrities explain the ...

https://theweek.com › speedreads › john-oliver-delightful-melange-celebrit...

18 hours ago - America's roughly 7,500 compounding pharmacies "exist for a very good reason," he explained: To make "bespoke medications" for people (and animals) with ...

Star-studded PSA against compounding pharmacies [Video]

https://www.yahoo.com › entertainment › celebrities-fight-back-after-bein...

20 hours ago - Celebrities joined Last Week Tonight With John Oliver to create a PSA against corrupt compounding pharmacies. Unlike traditional drug manufacturers and ...

USP delays official effective dates of new and revised ...

https://www.aha.org › news › headline › 2019-09-23-usp-delays-official-e...

3 days ago - Those standards include general chapters <795> (Pharmaceutical Compounding – Nonsterile Preparations), <797> (Pharmaceutical Compounding – Steril

FDA Cautions Pet Owners Not to Feed Performance Dog Raw Pet Food Due to Salmonella, Listeria monocytogenes

The U.S. Food and Drug Administration (FDA) is cautioning pet owners not to feed their pets any Performance Dog frozen raw pet food after a sample tested positive for Salmonella and Listeria monocytogenes (L. mono). Two samples of different finished products collected during an inspection of Bravo Packing, Inc., the manufacturer of Performance Dog raw pet food, tested positive for Salmonella and/or L. mono. One of the products sampled had not yet been distributed. The product that entered the marketplace is Performance Dog raw pet food, lot code 072219, sold to customers frozen in two-pound pouches.  However, the FDA is cautioning about all Performance Dog frozen raw pet food produced on or after July 22, 2019 because the products do not have lot codes printed on retail packaging. If you have any Performance Dog product that you purchased after July 22, 2019, throw it away. FDA is issuing this alert because Performance Dog raw pet food represents a serious threat to human and animal health. Because these products are sold and stored frozen, FDA is concerned that people may still have them in their possession. Salmonella and L. mono can affect both human and animal health. People with symptoms of Salmonella or L. mono infection should consult their health care providers. Consult a veterinarian if your pet has symptoms of Salmonella or L. mono infection.

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FDA Issues Draft Guidance on Expanded Conditional Approval for Certain Animal Drugs

The U.S. Food and Drug Administration today released draft Guidance for Industry, entitled “Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs,” to assist animal drug sponsors and potential sponsors who may be interested in pursuing conditional approval to market animal drugs  to address serious or life-threatening diseases or conditions, or an unmet animal or human health need, and for which demonstrating effectiveness would require complex or particularly difficult study or studies. Until recently, only new animal drugs intended for minor use in major species or for use in a minor species (MUMS) were eligible for conditional approval.  In 2018, as part of the reauthorization of FDA’s Animal Drug User Fee Act (ADUFA) program, Congress amended section 571 of the Federal Food, Drug and Cosmetic Act (FD&C Act) to expand FDA’s authority to grant conditional approval to include certain animal drugs for use in major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens) for diseases or conditions that would not be eligible for conditional approval under the MUMS provisions of the FD&C Act.   Expanded conditional approval has the potential to incentivize drug development and provide veterinarians with legally marketed new animal drugs to treat serious or life-threatening diseases or conditions and to fill treatment gaps where currently no therapies are available.

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Measles Patient Who Traveled Through LAX in September Might Have Exposed Others to Disease, Officials Warn POSTED 1:31 PM, SEPTEMBER 25, 2019, BY KRISTINA BRAVO, UPDATED AT 05:53PM, SEPTEMBER 25, 2019

https://ktla.com/2019/09/25/advisory-issued-after-person-who-traveled-through-lax-contracts-measles/

Remarks from Acting FDA Commissioner Ned Sharpless, M.D. as prepared for testimony before a U.S. House Energy and Commerce Subcommittee on FDA Regulation of Electronic Nicotine Delivery Systems and Investigation of Vaping Illnesses

Good morning, Chairwoman DeGette, Ranking Member Guthrie, and Members of the subcommittee.  Thank you for the opportunity to be here today to discuss the regulation of electronic nicotine delivery systems, or ENDS, and the Agency’s role in the ongoing investigation into lung injuries experienced by individuals who use vaping products.  As you know, prior to coming to FDA, I was Director of the NCI, and I’m a long-time cancer doctor. My experience treating patients has informed all of my work at the agency including the issues before the committee today.   We are here to discuss two top priority issues: first, the ongoing investigation into the cause of lung injury associated with the use of vaping products. Second, FDA’s ongoing efforts to ...

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