Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. In short, all studies found no significant difference between phenylephrine and placebo.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. Not surprisingly, the daughter suffered no injury at all from being vaccinated.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

Drug & Device Law

NOVEMBER 2, 2023

A court within the Fifth Circuit has held that the FDCA impliedly preempts unfair-competition and consumer-protection claims asserted by a drug manufacturer against a compounding pharmacy. 2023), because it rejects the use of state law to impose requirements beyond those imposed by the FDA. Pharmacy v. 2011)—reads Buckman Co.

Compounding Pharmacies 59

Compounding Pharmacies Pharmacy FDA Approval FDA 59

Drug & Device Law

JULY 24, 2023

To put that in context, the Actos label also carries the FDA’s most serious type of warning – a boxed warning – but for congestive heart failure, not bladder cancer. precipitously” after the 2011 label change adding the bladder cancer language, a “significant number” of claims would not have been reimbursed by TPPs nationwide.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. 2011), aff’d , 741 F.3d Other state laws affecting FDA-approved drugs are more likely to have the required protectionist bent.

Regulations 59

Regulations Production FDA FDA Approval 59

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. In GenBioPro, Inc.

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FDA Approval Pharmacy FDA Production 111

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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FDA FDA Approval Testimonials Vaccine 59