Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. only issued “the strongest ‘black box’ warning” against the drug in 2013.

Drugs 139

Drugs Science Research Doctors 139

Agency IQ

JUNE 7, 2024

Notifications will need to include the specific data requirements as laid out in Regulation (EU) No 283/2013 in Sections 1.3, of Part A of the Annex and “evidence that the notified substance or preparation is used as a safener or synergist in at least one plant protection product authorised in at least one Member State.”

Regulations 40

Regulations Animal Testing Production Marketing 40

Agency IQ

JANUARY 26, 2024

Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates. In some cases, manufacturers have determined that specific drug products have limited stability when the original packaging is opened.

Science 40

Science FDA Production Packaging 40

Agency IQ

AUGUST 4, 2023

BY LAURA DIANGELO, MPH AUG 3, 2023 8:21 PM CDT The Drug Supply Chain Security Act (DSCSA) and upcoming deadlines The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

FDA 40

FDA Science Production Packaging 40

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

JANUARY 12, 2024

In fact, CDER received a perfect 100% for meeting PDUFA dates for novel drugs in 2013, 2017, 2018 and 2020. The data used by AgencyIQ is obtained from reports put out by CDER and CBER , as well as approval letters and review packages posted to the Drugs@FDA database.

FDA 40

FDA Drugs Production Licensing 40

Agency IQ

JUNE 17, 2024

Between 2008 and 2013, Swiss and EU Commission experts had considered formalizing their relations concerning chemical safety. The two parties have entered into over 120 such agreements, though no bilateral agreement addressing chemical regulation exists.

Regulations 40

Regulations Production International Packaging 40

Agency IQ

JUNE 21, 2024

Industry would benefit from aligned submission packages and less work to create the submissions. Marketing authorizations holders will likely need to submit the same updates to international regulators to update their global authorizations. Some guidance on reliance procedures with regulators outside the E.U.

Regulations 40

Regulations Marketing Production Vaccine 40

LifeSciVC

APRIL 27, 2023

Our small team was able to support multiple major pharmaceutical companies plowing through diligence, not just withstanding the onslaught but in fact delivering a data package of Phase 3-ready quality. For further reading about Nimbus’ first chapter, many an excellent blog has been written about those formative days.

Small Molecule 40

Small Molecule Computational Chemistry Engineering Clinical Development 40

Agency IQ

APRIL 8, 2024

Once E2D(R1) has been finalized following comments received during public consultation, the note stated that “the final changes will be published via the E2B(R3) Implementation Guide package and ICH E2B(R3) Questions and Answers document.” This week, the FDA made significant progress towards the full implementation of E2B(R3) requirements.

FDA 40

FDA Production Regulations Vaccine 40

The Pharma Data

JUNE 18, 2021

8 VENCLEXTA (venetoclax) [Package Insert].?North?Chicago, BTK signaling is needed by specific cancer cells to multiply and spread. 4,5 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs. 2012;119(11):2590-2594. 7 IMBRUVICA U.S. Chicago, IL.:

Treatment 52

Treatment Therapies FDA FDA Approval 52

Practical Cheminformatics

JANUARY 3, 2023

However, after the Kaggle Merck Molecular Activity Challenge 2013 and the Tox21 Data Challenge 2015 , DNNs have emerged as the method of choice for QSAR applications in drug discovery.” A new package, Auto3D, from the Isayev group at Carnegie Mellon, could change this situation by making learned quantum chemical potentials very easy to use.

Drugs 40

Drugs Science Packaging Production 40

The Pharma Data

JUNE 18, 2021

9 VENCLEXTA (venetoclax) [Package Insert].?North BTK signaling is needed by specific cancer cells to multiply and spread. 5,6 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs. 2012;119(11):2590-2594. 8 IMBRUVICA U.S. Prescribing Information,?April

Treatment 40

Treatment FDA Therapies FDA Approval 40

Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

FDA 40

FDA Science Biosimilars Regulations 40

Agency IQ

MARCH 29, 2024

2) Update delivery timing and methods to require community water systems that serve 10,000 or more persons to provide reports biannually; and allow electronic delivery methods consistent with the “Safe Drinking Water Act–Consumer Confidence Report Rule Delivery Options” issued by the EPA on January 3, 2013.

Regulations 40

Regulations Compliance Production Government 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. On January 15, 2013, the EPA published a final rule in which the Agency retained the secondary standards for particulate matter.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

2) Update delivery timing and methods to require community water systems that serve 10,000 or more persons to provide reports biannually; and allow electronic delivery methods consistent with the “Safe Drinking Water Act–Consumer Confidence Report Rule Delivery Options” issued by the EPA on January 3, 2013.

Regulations 40

Regulations Compliance Production Science 40

Codon

NOVEMBER 1, 2024

This technique " opens large windows into the cell’s interior ," according to a 2013 review, allowing visualization of hidden structures that can’t be easily extracted or crystallized. More recently, Michael Elowitz's group — also at Caltech — published a method to study changes in RNA molecules within living cells.

DNA 122

DNA RNA Molecular Biology Laboratories 122

Codon

FEBRUARY 2, 2025

In 1965, Congress mandated labeling on all cigarette packaging that warned consumers about the risks of smoking. Obama’s 2013 White House solar installation generated about 19,700 kWh 13 annually ( just short of double what an average American household uses per year), at a time when residential solar systems were about $5/watt.

Disease 79

Disease Vaccine Nurses Engineering 79

Codon

FEBRUARY 23, 2025

ViiV Healthcare initially designed the drug, in 2013, by modifying the chemical structure of known integrase inhibitors to increase their potency. These challenges spurred researchers like Raphael Landovitz at UCLA to test a different drug, cabotegravir, as an intramuscular injection that could prevent HIV infections for long time periods.

Clinical Trials 70

Clinical Trials Virus Vaccine DNA 70

Drug & Device Law

JANUARY 31, 2024

Plaintiff’s fraud claims in Collyer allege that the packaging of four keto-friendly cereals was misleading because the cereals do not contain an ingredient pictured on the package. 2013) (state law claims preempted where they are dependent on a violation of federal law). Catalina Snacks Inc. LEXIS 9637 (N.D. 4 th at 1048).

Packaging 52

Packaging Production FDA Drugs 52

Drug & Device Law

DECEMBER 29, 2023

The G/N MDL was created in 2013 and mostly settled in 2016. Kampmann attacked a so-called “Daytime Convenience Pack” because one of the two separate items packaged together allegedly deceived consumers that it could independently treat the common cold. In re Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation , F.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

Drug & Device Law

AUGUST 3, 2023

472 (2013), had not arrived and plaintiffs had not stopped suing over alleged injuries from generic drugs. Plaintiffs did not even complain about the content of the package insert. The package insert is what most people think of as a prescription drug’s “label,” with its familiar format. Mensing , 564 U.S. Bartlett , 570 U.S.

Doctors 52

Doctors Packaging FDA FDA Approval 52

Drug & Device Law

JULY 31, 2023

Armstrong , 2013 WL 4853333, at *20-21 (E.D. 10, 2013) (free speech considerations precluded negligent misrepresentation suit over contents of a book); E.S.S. Palli , 2013 WL 1867072, at *4 (Conn. April 15, 2013); Tofolowsky v. 2013), vacated in part on reconsideration on irrelevant grounds , 2013 WL 1878934 (W.D.

Production 52

Production Trials International Government 52

Drug & Device Law

MAY 4, 2023

472 (2013), but that hinged largely on the duty of sameness—that is, the generic manufacturer cannot change the formulation of its drug to be different from the branded drug on which its ANDA approval depended. Ortho-McNeil-Janssen Pharms., 3d 281 (6th Cir. Bartlett , 570 U.S.

FDA Approval 64

FDA Approval FDA Regulations Production 64

Drug & Device Law

DECEMBER 19, 2022

one HDPE resin to another HDPE resin) of a packaging component that may affect the impurity profile of the drug product. 13, 2013). * * * *. (vi) Changes in a drug product container closure system that controls the drug product delivered to a patient or changes in the type (e.g., Current §§314.70(c)(6).

FDA 59

FDA Regulations Production Drugs 59

Drug & Device Law

SEPTEMBER 12, 2022

The case alleged on-label drug use between 2009 and early 2012, purportedly leading to plaintiffs’ decedent’s suicide in 2013 – more than a year after use of the drug had ceased. Both propositions are well recognized, but Pfaff ties them together in one neat package. citations omitted).

FDA 59

FDA FDA Approval Regulations Drugs 59

Drug & Device Law

JUNE 6, 2022

2013 WL 4516160, at *3 (N.M. 2013 WL 85291, at *8 (D.N.J. 7, 2013) (no causation given prescriber’s “testimony that he would prescribe [the drug] to Plaintiff again even with the benefit of the additional. . . 2013 WL 1758647, at *5 (D.N.J. SmithKline Beecham Corp. April 26, 2018); Cooper v. Bristol-Myers Squibb Co.

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

Drug & Device Law

MAY 30, 2022

1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. 2013 WL 2457950, at *8 (N.D. June 6, 2013) (no causation where the prescriber “believed that any risk associated with the drug was heavily outweighed by the benefits of treating what he suspected was. . .

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

FEBRUARY 24, 2022

2013), aff’d, 784 F.3d Implicitly relying on 21 U.S.C. § 2d at 777; accord, e.g. , Blankenship v. Medtronic, Inc. , 3d 979, 986 (E.D. 2014); Caplinger v. Medtronic, Inc. , 2d 1206, 1214 (W.D. 3d 1335 (10th Cir. 2015) (Gorsuch, J.).

Packaging 72

Packaging Regulations FDA Government 72