Document, FDA Approval and Packaging

ChEMBL 34 is out!

The ChEMBL-og

APRIL 16, 2024

New data have been included in the VERSION table to show the version applied for MeSH and EFO ontologies, the ChEMBL_Structure_Pipeline, RDKit packages, InChI, UniProtKB, Bioassay Ontology and Gene Ontology as well as the version of the ChEMBL database. University of Dundee: T. 1813 bioactivities in total have been added.

Clinical Trials

Clinical Trials FDA Cell Based Assays Compound Screening

Maximizing FDA PIND Feedback With an Optimized Nonclinical Strategy: 4 Tips to Streamlining Your Path to Clinic

The Premier Consulting Blog

APRIL 15, 2024

However, when it comes to an IND and supporting a clinical trial, FDA’s primary focus is on healthy volunteer and patient safety. It is critical that the nonclinical program outlined in the PIND briefing document is presented in a manner that allows FDA to provide relevant input on the required IND-enabling studies.

FDA

FDA Pharmacokinetics Laboratories FDA Approval

Article FDA Thank You FDA finalizes guidance on electronic submissions for OTC products

Agency IQ

JULY 26, 2024

FDA finalizes guidance on electronic submissions for OTC products FDA has fulfilled its commitment under the Over-the-Counter Monograph Drug User Fee (OMUFA) program to issue final guidance on how sponsors can electronically submit monographs and other documents. FDA-2022-D-2059 What should be submitted to which portal?

FDA

FDA Production Packaging Regulations

Webinars

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

MORE WEBINARS

Q&A: The IND Journey Phase I – Navigating Success

Advarra

JULY 19, 2022

A: For all vendors, having documented qualifications prior to use is important. For GMP vendors, documented reviews of records such as analytical testing and batch records, is also important. The auditor prepares by reviewing relevant information, such as contracts, as well as select QMS documents and records.

Packaging

Packaging FDA Trials Regulations

Release of ChEMBL 33

The ChEMBL-og

JUNE 13, 2023

We also time-stamped every document in ChEMBL with their CREATION_DATE! This fresh release comes with a few new data soures and also some new features: we added bioactivity data for understudied SLC targets from the RESOLUTE project and included a flag for Natural Products and for Chemical Probes. 270 K bioactivities.

Pharmacokinetics

Pharmacokinetics FDA Approval International Production

Fujifilm to Invest Over 200 Billion yen (2 Billion USD) to Establish New Large-Scale Cell Culture Manufacturing Site for Biopharmaceuticals in the U.S.A.

The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. Packaging line?. TOKYO , Jan. 8 x 20,000L bioreactors for mammalian cells.

Packaging

Packaging Small Molecule Production FDA Approval

FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters

FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. And the Guidance may be used as leverage to secure action from FDA on a meeting request.

FDA

FDA Drugs FDA Approval Packaging

Analysis Chemical Thank You FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance

Agency IQ

NOVEMBER 10, 2023

. | NOV 8, 2023 10:02 PM CST Regulatory background The Federal Food, Drug, and Cosmetics Act (FD&C Act) is administered by the Food and Drug Administration (FDA) and regulates cosmetics. MoCRA also requires all marketed cosmetic products to be listed with the FDA by December 29, 2023.

Production

Production FDA Compliance Packaging

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

To support industry’s accurate identification and updating of drug expiration dates, the FDA has released a handful of guidance documents for industry. Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients.

Science

Science FDA Production Packaging

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

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). The format of the PMI : At just one page (8.5×11

FDA

FDA FDA Approval Production Regulations

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

The term “drug product information” is now defined to include NDC, drug name, units per package size (UPPS), drug category (S, I, or N), unit type (e.g., Remarkably, manufacturers may not dispute a CMS notification.

Drugs

Drugs Regulations International Production

Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Agency IQ

NOVEMBER 3, 2023

The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. In fact, the FDA has even developed a guidance document for “early clinical trials with live biotherapeutic products [LBPs].”

Therapies

Therapies Science FDA Production

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

JULY 8, 2024

Still, three years later, the FDA reported that it had received several reports of medical gas mix-ups resulting in at least 8 patient deaths and 16 serious patient injuries between 1996 and April 2004. It also proposed several packaging changes to safeguard against misidentification. The Medical Gas Safety Act , introduced by Rep.

FDA

FDA Regulations Production Packaging

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

What we expect to be talking about in November and December: Diversity Action Plan guidance : There is perhaps no guidance that FDA is working on that is as hotly anticipated as its Diversity Action Plan (DAP) guidance, which is set for release anytime between now and December 29. Government shutdown: At present, the U.S.

FDA

FDA Science Regulations Production

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

JANUARY 19, 2024

The FDA CRL cited inspection findings that arose from a “multi-sponsor inspection of a third-party, contract manufacturing organization” which involved the monoclonal antibody drug substance for lebrikizumab. The clinical package, safety and label were not affected. However, BeiGene announced that it is seeking approval in the U.S.

Biosimilars

Biosimilars FDA Production Treatment

Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

The Pharma Data

AUGUST 6, 2020

See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. Oncology and Hematology. Regulatory. Regulatory.

Production

Production International Licensing Licensing

Article FDA Thank You AdComm votes in favor of new colorectal cancer screening test, but questions about serial testing and labeling remain

Agency IQ

MAY 31, 2024

sensitivity and specificity) – including colonoscopy procedures and an FDA-approved stool-based test ( Cologuard ) – but comparatively low uptake, given the prevalence of CRC in the population. Notably, CRC screening methods are currently available and have generally high performance (i.e.,

FDA

FDA Laboratories Compliance Packaging

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

Regulations

Regulations FDA Science Production

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Yancopoulos , M.D.,

Hospitals

Hospitals Production Clinical Trials Therapies

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

What we expect to be talking about in December and January: Diversity Action Plan guidance : There is perhaps no guidance that FDA is working on that is as hotly anticipated as its Diversity Action Plan (DAP) guidance, which is set for release anytime between now and December 29. This is what OIRA is currently reviewing.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. The budget agreement “asks” the FDA for some information and activities, and “recognizes” some FDA authority in other areas.

FDA

FDA Packaging Science Drugs

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

Agency IQ

JANUARY 12, 2024

After lengthy review, FDA approves Florida’s drug importation plan After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada. Drug labeling : Labeling for the imported drug product must be consistent with the current required U.S.

FDA Approval

FDA Approval FDA Science Drugs

Merck KGaA raises full-year forecast; Perlmutter’s new gig tackles ‘undruggable targets’

The Pharma Data

MAY 5, 2021

FDA approves 100th monoclonal antibody product ( Nature Reviews Drug Discovery ). AI, digital health feature in latest batch of FDA breakthrough device designations ( MedTech Dive ). BD Taps Contract Packager for COVID-19 Test Kits ( MD+DI ). Medtech.

Vaccine

Vaccine FDA FDA Approval International

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. See 2023 Mich.

Testimonials

Testimonials FDA Drugs Vaccine

Another Favorable Post-Albrecht MDL Preemption Decision

Drug & Device Law

SEPTEMBER 12, 2022

Both propositions are well recognized, but Pfaff ties them together in one neat package. The FDA decided against it, but “did not also inform the [defendant].” When the FDA approved [defendant’s] supplemental CBE in 2011, [defendant] was not aware of the impossibility of adding a suicidality warning under federal law.

FDA

FDA FDA Approval Regulations International

Drug Discovery Digest

ChEMBL 34 is out!

Maximizing FDA PIND Feedback With an Optimized Nonclinical Strategy: 4 Tips to Streamlining Your Path to Clinic

Article FDA Thank You FDA finalizes guidance on electronic submissions for OTC products

Webinars

Q&A: The IND Journey Phase I – Navigating Success

Release of ChEMBL 33

Fujifilm to Invest Over 200 Billion yen (2 Billion USD) to Establish New Large-Scale Cell Culture Manufacturing Site for Biopharmaceuticals in the U.S.A.

FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters

Analysis Chemical Thank You FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

Article FDA Thank You AdComm votes in favor of new colorectal cancer screening test, but questions about serial testing and labeling remain

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

Merck KGaA raises full-year forecast; Perlmutter’s new gig tackles ‘undruggable targets’

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Another Favorable Post-Albrecht MDL Preemption Decision

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