Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. Data from pharmaceutical legislation is not included by default, though some specifically named pharma data relating to chemicals will be encompassed.

Packaging

PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. PPD ® Laboratory services are backed by a proven track record with over three decades of experience providing CMC pharmaceutical testing.

Laboratories

The Premier Consulting Blog

MAY 4, 2023

Food and Drug Administration (FDA) published in March of 2022 pertaining to ophthalmic drugs and devices, titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product.

FDA

Fierce BioTech

JANUARY 12, 2024

Developing and Manufacturing Minitablets to Extend Drug Lifecycle pesurya Fri, 01/12/2024 - 12:38 Wed, 02/28/2024 - 11:00 Resource Type Webinar Robert Strickley, PhD Valjon Demiri, MSc Duration 60 Minutes Oral minitablets can offer several advantages in pharmaceutical applications, making them a valuable option in drug delivery.

Drugs

The Premier Consulting Blog

NOVEMBER 8, 2022

e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., typical drug device, biologic device) Two or more separate components, co-packaged (e.g., e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., Also see the FDA’s FAQs on this topic.)

Production

Agency IQ

MARCH 15, 2024

California implements a variety of extended producer responsibility (EPR), programs, including programs to address paint, carpet, mattress, pharmaceutical and battery waste. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

Regulations

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

The Premier Consulting Blog

NOVEMBER 16, 2022

For example, they may develop a long-acting formulation that improves patient compliance or use a new route of administration that improves efficacy or increases ease of use. Involving nonclinical/toxicology experts early on is key to reducing the package of studies as much as possible. What is an excipient?

FDA

Drug Target Review

DECEMBER 5, 2024

2 However, utilisation of biological systems introduces variability and by-products, as well as a challenge unique to AAV production: the assembly of full capsids with correctly packaged DNA, partially filled capsids containing partial vector and/or host cell DNA, and empty capsids.

Therapies

Agency IQ

SEPTEMBER 6, 2023

This impact was apparently enough for the FDA and generic pharmaceuticals industry to include a new meeting type in the most recent iteration of the Generic Drug User Fee program (GDUFA), called a “Post-Warning Letter Meeting.” What should the meeting request package include?

FDA

FDA Law Blog: Biosimilars

JULY 15, 2025

For example, in 2016, CMS explained that, “[g]iven the continually changing pharmaceutical marketplace, we will continue to allow manufacturers the flexibility to determine the fair market value of a service when evaluating whether the service fee is bona fide or not.”

Regulations

FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

The Guidance which is the subject of this blogpost specifically provides that it is applicable to facilities which manufacture either generic drugs or active pharmaceutical ingredients for generic drugs. The Guidance advises that the meeting request not be submitted until “significant progress” toward remediation has been made.

FDA

Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Parliament voted on the extension to the diagnostic regulation (IVDR) compliance deadlines in plenary this week.

Regulations

Advarra

SEPTEMBER 23, 2022

Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : . Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. .

Clinical Trials

Agency IQ

JANUARY 12, 2024

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. However, according to the OPQ reviews , approvability as of April 24 was still pending “final determination of compliance status of the manufacturing facilities” located in Ireland.

FDA

Agency IQ

AUGUST 25, 2023

The questions contained in the letter are organized into six high-level topics : (1) current market dynamics; (2) (regulatory) pathway; (3) federal-state interaction; (4) safety; (5) quality; and (6) form, packaging, accessibility, and labeling. The letter gave respondents until August 18, 2023 to respond to the request.

Regulations

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

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

Agency IQ

OCTOBER 27, 2023

Comment periods for EMA documents (such as concept, reflection, and guidance papers) generally stay open for at least six months, though these timelines can vary drastically. policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

Regulations

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. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

Regulations

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. 2021 Expectations % Change vs 2020 Earnings per share (reported) $6.73 44 Acquired IPR&D (a).38

Production

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. and markets outside the U.S. and markets outside the U.S.

Production

Agency IQ

JUNE 16, 2023

There would also be cost savings to both FDA and industry from facilitating the review of documentation that ensures compliance with our regulations prior to being allowed to enter the United States. This action is being undertaken to revise regulations that required paper submission in duplicate, triplicate, etc.

Regulations

Agency IQ

MAY 3, 2024

and the E.C.

FDA

Agency IQ

JUNE 21, 2024

The European Commission has issued a guideline to facilitate compliance with the Variations Regulation; the Annex in that document provides a detailed overview of post-authorization changes and their associated variation categories. In April 2023, the Commission issued proposals to revise the current pharmaceutical Directive and Regulation.

Regulations

The Pharma Data

JANUARY 9, 2021

This growth primarily reflects increased sales of contract development and manufacturing (CDMO) services to pharmaceutical and biotechnology innovators and government/non-government organization (NGO) customers, as well as higher product sales. Other 2021 Assumptions. FOOTNOTES. (1)

Government

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

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

Agency IQ

JANUARY 12, 2024

But while the plan may be approved, the decision by FDA still leaves open plenty of questions – and the potential that pharmaceutical trade groups may sue to halt the implementation of the plan. label for that product, including patient labeling such as Medication Guides and patient package inserts.

FDA Approval

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

Codon

JANUARY 21, 2024

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. We have to ensure compliance but can’t guarantee that a participant is always going to use barrier contraception.

Vaccine

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

Drug & Device Law

JULY 31, 2023

Medicis Pharmaceutical Corp. , Smith rejected plaintiff’s analogy between books and drug package inserts. vs. Ortho-McNeil-Janssen Pharmaceuticals , 2013 WL 2917651 (Pa. Ortho-McNeil-Janssen Pharmaceuticals , 2013 WL 3480286, at *7-11 (Pa. Ortho-McNeil-Janssen Pharmaceuticals , 2013 WL 2321107, at *6-8 (Pa.

Production

Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). Negligence requires an evaluation of a defendant’s reasonableness, and all relevant NC authority includes relevant regulatory compliance in that mix. 4th 851 (6th Cir. denied , 144 S. 4th 696 (3d. Strike one.

Testimonials

Drug Patent Watch

MARCH 25, 2025

Breaking into the Generic Drug Market: Strategies for Success As a pharmaceutical professional, you know that the generic drug market is a highly competitive space. Another important strategy is to invest in quality and compliance. But what sets the successful generic drug companies apart from the rest?

Marketing

Perficient: Drug Development

OCTOBER 14, 2024

Industry-specific Attributes: Chemicals, electronics, pharmaceuticals, etc. Example: An electronics company classifies items into components, finished products, and packaging materials. Example: A pharmaceutical company classifies its items into active pharmaceutical ingredients (APIs), excipients, and packaging materials.

Packaging