Biosimilars, Compliance and Packaging

ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products – West Coast Edition

FDA Law Blog: Biosimilars

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M.

Compliance

Compliance Production Packaging Government

What is Special about September 24, 2023 for the UDI System?

FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

Packaging

Packaging Compliance FDA Production

Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference

FDA Law Blog: Biosimilars

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant. By John W.M. Truly, these are complex considerations.

Production

Production Compliance Regulations FDA

Trading Partners May Exhale: FDA Releases Guidance Exercising a Year-Long Period of Enforcement Discretion Related to DSCSA Enforcement of Certain Provisions

FDA Law Blog: Biosimilars

AUGUST 27, 2023

The compliance policies described in the Guidance focus on the requirement that, beginning November 27, 2023, all trading partners generally will be required to use electronic-based approaches to meet the enhanced drug distribution security requirements set forth in in FDCA section 582(g)(1) (Enhanced Drug Distribution Security).

FDA

FDA Packaging Production Drugs

FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

FDA

FDA Regulations Packaging Compliance

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

FDA Law Blog: Biosimilars

MARCH 3, 2024

This guidance will be critical because the Act leaves open a number of key questions that would be important to compliance and changes to the FAR are not required until a year after the guidance—and therefore after the effective date.

Small Molecule

Small Molecule Government FDA Approval Regulations

Article EMA Thank You What we expect European regulators to do in May 2024

Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. Parliament voted on the extension to the diagnostic regulation (IVDR) compliance deadlines in plenary this week.

Regulations

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Article EMA Thank You What we expect European regulators to do in June 2024

Agency IQ

MAY 31, 2024

Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package. The current European Parliament and Commission have confirmed their position on the pharma package, but the European Council is still working on its negotiation position.

Regulations

Regulations Production Compliance Pharmaceuticals

Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

FDA Law Blog: Biosimilars

JUNE 12, 2023

Although many states adopt or reference AAFCO’s Model Bill for Pet and Specialty Pet Food, often the nuanced application or understanding of these model regulations by an individual state or individual regulator creates a barrier for compliance in one state, while the same product with the same packaging passes scrutiny in others.”

Regulations

Regulations FDA Production Government

Article EMA Thank You What we expect European regulators to do in November 2023

Agency IQ

OCTOBER 27, 2023

policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

Regulations

Regulations Pharmaceuticals Production Packaging

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA

FDA Science Regulations Clinical Trials

Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed.

Regulations

Regulations Clinical Trials Production Trials

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

FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

The Guidance advises that the meeting request not be submitted until “significant progress” toward remediation has been made.

FDA

FDA Drugs FDA Approval Packaging

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

Agency IQ

OCTOBER 27, 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. Comments on the proposal closed on July 19.

FDA

FDA Science Regulations Production

Lilly Delivers Strong Second-Quarter 2021 Financial Results, Updates 2021 Financial Guidance

The Pharma Data

AUGUST 3, 2021

The company confirmed the tirzepatide SURPASS program has met global regulatory submission requirements for evaluating cardiovascular risk and its intention to submit the registration package to regulatory authorities by the end of 2021. Revenue outside the U.S. decreased 28 percent to $95.6 million, primarily driven by decreased volume.

Production

Production Marketing Research DNA

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

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. Comments on the proposal closed on July 19.

FDA

FDA Science Regulations Production

Drug Discovery Digest

ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products – West Coast Edition

What is Special about September 24, 2023 for the UDI System?

Trending Sources

Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference

Trading Partners May Exhale: FDA Releases Guidance Exercising a Year-Long Period of Enforcement Discretion Related to DSCSA Enforcement of Certain Provisions

FDA Issues Long-Awaited QMSR Final Rule

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

Article EMA Thank You What we expect European regulators to do in May 2024

Article EMA Thank You What we expect European regulators to do in June 2024

Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

Article EMA Thank You What we expect European regulators to do in November 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Article EMA Thank You What we expect European regulators to do in August and September 2024

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

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

Lilly Delivers Strong Second-Quarter 2021 Financial Results, Updates 2021 Financial Guidance

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

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