Agency IQ

AUGUST 4, 2023

pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. Pharmaceutical Directive. s official exit from the E.U. as of January 1, 2021.

Packaging 40

Packaging Licensing Licensing Regulations 40

The Pharma Data

AUGUST 3, 2021

SOLIRIS is a registered trademark of Alexion Pharmaceuticals, Inc. In anticipation of future demand for our medicines, we will invest approximately $1 billion to build two new manufacturing facilities – a packaging plant in Ohio and a drug substance plant in North Carolina. XmAb is a registered trademark of Xencor, Inc. Tax Petition.

Biosimilars 52

Biosimilars Production Treatment FDA 52

Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

Engineering 85

Engineering Vaccine Production RNA 85

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

0910-AI84 December 2023 Final Rule Stage Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

DECEMBER 1, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 15, 2023

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 Production Government 40

Agency IQ

JUNE 16, 2023

The EPA is also proposing our response to a petition regarding the continued validity of EPA’s 2012 determination (and September 2017 affirmation) that participation in the Cross State Air Pollution Rule (CSAPR) meets the Regional Haze Rule’s criteria for an alternative to the application of source-specific BART.

Regulations 40

Regulations Compliance Production Science 40

Codon

JUNE 26, 2023

For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) The excellent Retraction Watch blog, where I briefly worked while studying at New York University, has been covering Macchiarini since 2012. Nevertheless, phage therapy did have a stint in the U.S. Throughout the 1940s, several U.S.

DNA 52

DNA Therapies Engineering Clinical Trials 52

Codon

JUNE 26, 2023

For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) The excellent Retraction Watch blog, where I briefly worked while studying at New York University, has been covering Macchiarini since 2012. Nevertheless, phage therapy did have a stint in the U.S. Throughout the 1940s, several U.S.

DNA 52

DNA Therapies Engineering Clinical Trials 52

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. 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 Government Science 40

Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40

Drug & Device Law

JULY 31, 2023

2012), computer code was not a “product” for purposes of the National Stolen Property Act, 18 U.S.C. 2012 WL 5932437 (N.D. 27, 2012), limited the undefined term “product” in an Alabama sales commission statute to tangible things, excluding franchise rights. 3d 316, 338 (Alaska 2012). Medicis Pharmaceutical Corp. ,

Production 52

Production International Trials Government 52

Drug & Device Law

MAY 30, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 2012) (no proof that hypothetical “Dear Doctor letter” or on-product warning would have causal effect given that risk had arisen only once in implanter’s several thousand similar surgeries) (applying Tennessee law); Eck v. Janssen Pharmaceuticals, Inc.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

JUNE 6, 2022

2012), it had to apply the rule. Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d Janssen Pharmaceuticals , 2018 WL 1977258, at *12 (Mag. Teva Pharmaceuticals USA, Inc. , Novartis Pharmaceuticals Corp. , Hamilton , 372 S.W.3d 3d 140 (Tex. Salinero also followed the recent Hubbard v.

Testimonials 59

Testimonials Production Pharmaceuticals Treatment 59