Agency IQ

SEPTEMBER 29, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

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FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

Date What’s Happening Explanation Source October 31 FDA deadline on Florida drug importation plan The FDA has said in court filings that it plans to make a ruling on Florida’s prescription drug importation plan by October 31. The following PDUFA dates were obtained from publicly available sources. to include devices.

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3210 Accelerated Approval : FDA’s Accelerated Approval Council must publish a report within one year of the passage of the FDORA legislation regarding its annual activities. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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Agency IQ

JUNE 16, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

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Regulations FDA Science Production 40

Drug & Device Law

JULY 24, 2023

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , Takeda Pharmaceutical Co. , 2014) (both complete with diagrams). 3d 1243 (9th Cir. 3d , 2023 WL 4191651 (C.D.

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Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

MARCH 16, 2023

In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician). 2014) (Pennsylvania law), mucked things up and cases like Yates v. Wyeth , 619 F.3d

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FDA Approval FDA Testimonials Production 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

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