Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

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Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

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FDA Science Regulations Clinical Trials 40

Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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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. In June, the company and Acceleron Pharma Inc. Regulatory.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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FDA Science Regulations Production 40

Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months.

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Vaccine Trials Disease Treatment 108

The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers. FOOTNOTES. (1)

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The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Numbers may not add due to rounding.

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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.

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FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

EPA is also incorporating a requirement for states to report comprehensive compliance monitoring data annually to the Agency. To further reinforce consumers’ right-to-know as intended by Congress, EPA is also incorporating a requirement for states to report comprehensive compliance monitoring data annually to the Agency.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

JANUARY 12, 2024

The supply chain could only contain three entities: The manufacturer, the Foreign Seller (who must also be a licensed wholesaler by Health Canada), and the importer. label for that product, including patient labeling such as Medication Guides and patient package inserts.

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Drug & Device Law

JULY 31, 2023

However, licensed software can be a UCC sale of “goods.” Smith rejected plaintiff’s analogy between books and drug package inserts. Rather, Lowe relied on broadly applicable negligence principles involving consumer expectation and compliance with industry standards, as it would for any run-of-the-mill tangible product.

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Production International Trials Government 52

Drug & Device Law

DECEMBER 29, 2023

Negligence requires an evaluation of a defendant’s reasonableness, and all relevant NC authority includes relevant regulatory compliance in that mix. Plaintiffs’ own litigation strategy thus opened the door to compliance evidence. The case was governed by North Carolina substantive law, and NC rejects strict liability altogether.

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Testimonials FDA Drugs Vaccine 105

Drug & Device Law

NOVEMBER 1, 2022

Punitive damages also failed as a matter of law under Arizona’s compliance defense.

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Testimonials FDA FDA Approval Packaging 59

Drug & Device Law

MAY 22, 2023

Fifth , the Montana law creates a qualified safe harbor for regulatory approval and compliance. This is a big change, because Montana had been one of only two states (the other being Pennsylvania) where compliance evidence was inadmissible in strict liability actions if offered by defendants.

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