Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. Chinese researchers scoured ancient medical texts containing written records of malaria outbreaks and the plant-derived recipes that were used to treat them nearly two thousand years ago.

Drugs 138

Drugs Science Research Doctors 138

Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI).

FDA 40

FDA FDA Approval Production Regulations 40

Agency IQ

APRIL 8, 2024

Namely, the use of “social media, market research programs, patient support and assistance programs,” as noted in the concept paper , have now been addressed. For BA/BE studies that do not require INDs (a majority of those used in support of generic drug applications), only a subset of FDA’s regulations regarding clinical research apply.

FDA 40

FDA Production Regulations Vaccine 40

Agency IQ

NOVEMBER 20, 2023

During an annual update on the program and its various workstreams, regulators and researchers discussed ongoing projects at Sentinel, its work under the current Prescription Drug User Fee authorization (PDUFA) program and next steps in using active surveillance for regulatory purposes.

Science 40

Science FDA Research Regulations 40

Agency IQ

DECEMBER 1, 2023

The Gasoline Distribution NESHAP, subparts R and BBBBBB, were promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on December 14, 1994, and January 10, 2008, respectively. In 2009, the EPA granted reconsideration on a petition to reconsider the 2008 rule and subsequently issues an administrative stay of the 2008 rule.

Regulations 40

Regulations Production Science Compliance 40

Agency IQ

OCTOBER 27, 2023

The Gasoline Distribution NESHAP, subparts R and BBBBBB, were promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on December 14, 1994, and January 10, 2008, respectively. EPA recently reclassified several areas as Severe nonattainment areas for the 2008 ozone NAAQS.

Regulations 40

Regulations Compliance Science Production 40

The Pharma Data

MAY 15, 2021

I knew I needed to take my research “off-grid”, and…. …on This is an unbelievably exciting package… designed you so don’t risk a single cent putting it to the test in your own home. It contains all of my research, tests, experiments and “top secret” programming. They obviously didn’t know who they were talking to. Check it out….

Production 52

Production Packaging Doctors Science 52

Agency IQ

MARCH 29, 2024

The Gasoline Distribution NESHAP, subparts R and BBBBBB, were promulgated pursuant to section 112(d) of the Clean Air Act(CAA) on December 14, 1994, and January 10, 2008, respectively.

Regulations 40

Regulations Compliance Production Government 40

Codon

FEBRUARY 9, 2025

Since the emergence of visualization technologies, such as electron microscopy (EM) and functional MRI (fMRI), scientists have been able to examine healthy brains for data about everything from the movement of water molecules inside axons to the precise location of neural activation when a research subject is asked to do arithmetic in their head.

Research 100

Research Disease Engineering Regulations 100

Agency IQ

FEBRUARY 2, 2024

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA is not considering methods for new analytes in this routine MUR.

Regulations 40

Regulations Compliance Engineering Government 40

Agency IQ

JANUARY 4, 2024

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. Circuit granted EPA a voluntary remand in 2008 for the Agency to re-evaluate the MACT floors established in 1995 based on the D.C. EPA, 358 F.3d 3d 936 (D.C.

Regulations 40

Regulations Government Compliance Science 40

Drug & Device Law

JULY 31, 2023

2008 WL 11344752, at *2 (D. April 22, 2008); Isham v. 2008 WL 2622791, at *4 (N.D. July, 1, 2008) (“provision of a manual for software does not convert the transaction from one for a software service to one for both tangible goods and service”). 2008) (all quoting and following Pierson definition of product).

Production 52

Production Trials International Government 52

Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . 2008) (applying Texas law and discussed here ), several times. 2008); In re Pradaxa Cases , 2019 WL 6043514, at *5-6 (Cal.

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

Drug & Device Law

MAY 16, 2022

Council for Education & Research on Toxics , 29 F.4th One major group (the National Cancer Institute, as well as scientific researchers, found that “a large number of epidemiologic studies in humans have found no consistent evidence that dietary acrylamide exposure is associated with the risk of any type of cancer.” 4th at 478.

Government 59

Government Production Packaging FDA 59

Drug & Device Law

MARCH 16, 2022

In Arizona, a manufacturer cannot be liable for punitive damages if the product was “designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.”

FDA 69

FDA Production Trials Government 69