SQA

MAY 24, 2023

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

SQA

MAY 24, 2023

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

SQA

DECEMBER 16, 2022

This proposal builds upon the existing legal framework, which came into force in 2002 for blood and 2004 for tissues and cells. It also fosters innovation in this crucial biotech sector. The framework contains parallel provisions for donor selection, quality and safety management and oversight.

FDA 40

FDA Compliance COVID-19 Licensing 40

Health Law Advisor

AUGUST 10, 2023

FDA specifically identified the following as not having to register as device manufacturers: Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice. [8] 8] We could go on, but hopefully you get the gist.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

FEBRUARY 26, 2024

These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002. Sponsors need to have systems in place to monitor the performance of the devices they supply, receive, update, and maintain information about their devices and report details of adverse events and performance issues to us.

FDA 52

FDA Compliance COVID-19 Public Health 52

SQA

FEBRUARY 26, 2024

Sponsors need to have systems in place to monitor the performance of the devices they supply, receive, update, and maintain information about their devices and report details of adverse events and performance issues to us.These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002.

FDA 40

FDA Compliance COVID-19 Public Health 40

Drug & Device Law

FEBRUARY 19, 2024

That regulation provides that a prescription-only drug – one that can only be obtained through “a practitioner licensed by law to administer or prescribe such drugs” bearing “[t]he statement ‘Rx only’” – is “exempt” from requirements to provide adequate directions for use to patients. Ortho Pharmaceutical Corp., 2d 522, 528 (Or. Griffith v.

FDA 52

FDA Licensing 52

Drug & Device Law

JANUARY 4, 2024

2002); Tracker Marine, L.P. 2002 WL 32830975, at *4 (Tex. May 15, 2002); Bass v. See Henry Schein, Inc. Stromboe , 102 S.W.3d 3d 675, 698 (Tex. Ogle , 108 S.W.3d 3d 349, 358 (Tex. 2003); Birdsong v. Toyota Motor Credit Corp. Hendrix , 931 F. 523, 529 (S.D. 1996) (all refusing to apply DTPA extraterritorially). 247d-6d(b)(8).

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59

Drug & Device Law

NOVEMBER 9, 2023

357 (2002); United States v. The FDA, of course, has long thought otherwise, but as we have discussed in the above prior posts, it has been piling up losses on this issue over the last couple of decades. E.g. , Sorrell v. IMS Health Inc. , 552 (2011); Thompson v. Western States Medical Center , 535 U.S. Caronia , 703 F.3d 3d 149 (2d Cir.

FDA 64

FDA Health Insurance Nurses Medicare 64

Drug & Device Law

JULY 31, 2023

2002), held that a videogame could not be a “product” for strict liability purposes. “[I]n considering whether to recognize a new tort recovery theory, the Colorado courts give great weight to the theory’s impact on free expression.” Connecticut Connecticut’s products liability statute does not define the term “product.” See Conn.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

FEBRUARY 2, 2023

Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. March 4, 2005), rev’d on other grounds , 462 F.3d 3d 364 (5th Cir. American Home Products Corp. ,

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

JUNE 13, 2022

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Bard, Inc. , 3d 1272 (11th Cir.

FDA 59

FDA Licensing Doctors Nurses 59

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . 2002), aff’d , 356 F.3d American Cyanamid Co. , 3d 496, 514 (6th Cir. Synthes Spine Co. ,

Doctors 59

Doctors Licensing Informed Consent Hospitals 59