Agency IQ

JUNE 17, 2024

To put it bluntly: If standing to sue could be demonstrated by a physician who merely potentially treats a patient who may experience side effects, then presumably there would be little to protect the FDA from lawsuits filed by any physician against any drug or product the FDA approves.

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Agency IQ

SEPTEMBER 29, 2023

AgencyIQ / FDA October 1 PAHPA Authorization lapses Unless reauthorized by Congress – and at this point, it’s looking unlikely – programs operating under the authority of the Pandemic and All-Hazards Preparedness Act and requiring reauthorization will cease to exist as of the start of the fiscal year. This is what OIRA is currently reviewing.

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Agency IQ

OCTOBER 27, 2023

What we expect to be talking about in November and December: Diversity Action Plan guidance : There is perhaps no guidance that FDA is working on that is as hotly anticipated as its Diversity Action Plan (DAP) guidance, which is set for release anytime between now and December 29. Government shutdown: At present, the U.S.

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Agency IQ

DECEMBER 1, 2023

What we expect to be talking about in December and January: Diversity Action Plan guidance : There is perhaps no guidance that FDA is working on that is as hotly anticipated as its Diversity Action Plan (DAP) guidance, which is set for release anytime between now and December 29. This is what OIRA is currently reviewing.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. to include devices in order to implement FDA’s new authority under section 2 of the Safeguarding Therapeutics Act (Pub.

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Drug & Device Law

JULY 24, 2023

at *6 (plaintiff “has documents and formularies reaching back to only 2009”). This time-tested type of evidence is mostly absent from the analysis in PATDC82 II – as in Neurontin , the only actual prescriber testimony belied plaintiffs’ position. First, the class plaintiff got away with destruction of evidence.

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Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. They excluded bogus expert testimony under Fed. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir.

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