The Pharma Data

APRIL 27, 2021

They are among the first products certified under the new European In Vitro Diagnostics Regulation (IVDR) and available as of today in countries accepting CE mark. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. Stroke (2005); 36(6):1115-1119.

Treatment 40

Treatment Disease Pharmaceuticals Therapies 40

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science 40

Science FDA Production Packaging 40

Agency IQ

FEBRUARY 2, 2024

In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance. The pharmaceutical trade association EFPIA has released its comments on the concept paper , however. The document has been updated over time to implement advances in understanding cancer and drug development. novel methodology qualification.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40

The Pharma Data

NOVEMBER 2, 2020

To this end, the Board of Directors shall be entitled to make adjustments to meet foreign regulations or market conditions, including resolving on cash or other settlement if deemed favorable for Oncopeptides based on foreign tax regulations. Rein Piir, Head of Investor Relations at Oncopeptides, E-mail: rein.piir@oncopeptides.com.

Marketing 40

Marketing Regulations Pharmaceutical Companies Packaging 40

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations 40

Regulations Compliance Production Science 40

Drug Target Review

NOVEMBER 27, 2024

Advanced techniques like liquid chromatography tandem mass spectrometry (LC-MS/MS) and Meso Scale Discovery (MSD) provide the kind of comprehensive and reliable data increasingly favoured by regulators, yet many researchers continue to rely exclusively on enzyme-linked immunosorbent assay (ELISA). This is a misconception.

Drug Development 52

Drug Development Regulations Laboratories FDA 52

Drug & Device Law

JANUARY 15, 2024

It is not evidence of the underlying attributes of the product that make it compliant with regulations or standards, which is presumably admissible subject to the ordinary Rules of Evidence. We] “borrow” the OSHA regulation for use as evidence of the standard of care owed to plaintiff. Janssen Pharmaceuticals, Inc. ,

Compliance 52

Compliance Government Production FDA Compliance 52

Drug & Device Law

OCTOBER 23, 2023

Thus, “the MDA sets forth a general rule pre-empting state duties having the force and effect of law (whether established by statute, ordinance, regulation, or court decision ). Ortho Pharmaceutical Corp. , 2005); Cuyler v. at 328 (citation omitted). at 329 (citation and quotation marks omitted) (emphasis original).

Government 59

Government Regulations FDA Nurses 59

Drug & Device Law

JULY 31, 2023

The 2005 revisions to Article 2 excludes “information” from the definition of goods and also defines computer software as “information.” 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Medicis Pharmaceutical Corp. , City of Madera , 2005 WL 1683736, at *13 (E.D.

Production 52

Production Trials International Government 52

Drug & Device Law

JUNE 1, 2023

2005) (“the trial judge, when presented with a proffer of expert scientific evidence, must initially perform a gatekeeping function in order to determine if the reasoning behind the evidence is scientifically valid and can be applied to the facts of the case”). Merrell Dow Pharmaceuticals, Inc. , 2005); In re Doe , 981 P.2d

Testimonials 59

Testimonials Trials Science Government 59

Drug & Device Law

JANUARY 30, 2023

2019), or Mutual Pharmaceutical Co. 280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Kent , 552 U.S.

FDA 72

FDA Regulations Production Government 72

Drug & Device Law

AUGUST 9, 2022

However, when it comes to federal preemption of a failure to warn claim involving a prescription pharmaceutical, the only new knowledge that counts is the FDA’s. Failure to warn is not preempted if the defendant could have changed the label without FDA approval via the Changes Being Effected (CBE) regulation. Long live enlightenment.

FDA Approval 52

FDA Approval FDA Regulations Government 52

Drug & Device Law

MARCH 28, 2022

Ferring Pharmaceuticals, Inc. A lot of the discussion in Tsao was case specific because the purported expert opinions at issue were among the most ridiculous we’ve ever seen – directly contrary to the controlling FDA regulations applicable to the particular drug. So we ran a search. High on the list was Tsao v. 2018 WL 3649714 (S.D.

Testimonials 59

Testimonials FDA Regulations Production 59