FDA Law Blog: Biosimilars

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

Documentation 59

Documentation Packaging Clinical Pharmacology Drug Development 59

European Pharmaceutical Review

APRIL 8, 2025

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.

Documentation 52

Documentation Packaging Pharmaceutical Manufacturing 52

European Pharmaceutical Review

DECEMBER 19, 2023

The document was adopted by EMA’s Management Board at its December meeting. Preparations to support the implementation of the EU AI Act will start in 2024. AI-supported spectroscopy delivers superior pharmaceutical packaging QC The post European regulators prepare for AI in pharma appeared first on European Pharmaceutical Review.

Packaging 105

Packaging Documentation 105

European Pharmaceutical Review

APRIL 10, 2025

billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment. However, given that PFAS are ubiquitous in the environment from stain-resistant carpets and non-stick pans, to packaging and electronics, to name a few the task is not that simple.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Packaging Documentation Communication 59

Express Pharma

MARCH 16, 2025

What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceutical manufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands. Regulatory bodies in the U.S.

Biosimilars 110

Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 110

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. By Deborah L. 89 FR 74966 at 74968 (Sept.

Documentation 59

Documentation Packaging 59

Express Pharma

SEPTEMBER 19, 2024

These three co-located trade fairs bring together a wide array of technologies under one roof, covering the entire spectrum of laboratory technology, life sciences, pharmaceuticals, and packaging.  There will be case study presentations on CAPA, precision lighting, ergonomic seating in classrooms, and building operational excellence.

Packaging 105

Packaging Documentation 105

GMPSOP

MARCH 30, 2024

Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch. Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Big Molecule Watch

JANUARY 5, 2024

Regeneron seeks a PI schedule to “ensure an orderly process that will result in resolution of its forthcoming motion for PI before May 17, 2024,” when its regulatory exclusivity period ends. The proposed schedule also provides dates for document discovery and depositions. Specifically, Regeneron has asserted the following patents.

Packaging 49

Packaging Documentation Biosimilars 49

Proxsys Rx

APRIL 19, 2024

And that is why the one 340B prediction we can make for 2024, unequivocally, is repeated three times in this post’s headline. Which means we may see a lot more states putting manufacturers in their place, in 2024. How covered entities should prepare for 340B changes in 2024 Build a qualified 340B team. And More Change.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Drug Pricing Packaging 52

National Association of Boards of Pharmacy

OCTOBER 23, 2024

Full enforcement of the  Drug Supply Chain Security Act  (DSCSA) was set to begin on November 27, 2024, at the conclusion of the one-year FDA Stabilization Period. On October 10, 2024, U.S. Food & Drug Administration (FDA) issued an exemption notice for certain DSCSA requirements. We support this decision.

Packaging 50

Packaging Documentation Pharmacy Technician 50

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. includes considerations with respect to documentation, applicable regulatory requirements, design and development, and enforcement.

Labelling 59

Labelling Packaging Documentation 59

Quality Matters

NOVEMBER 5, 2024

API DMFs are documents containing information on APIs that are submitted to the U.S. Food and Drug Administration (FDA) by API manufacturers to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.

Pharmaceutical Manufacturing 78

Pharmaceutical Manufacturing Packaging Documentation 78

National Association of Boards of Pharmacy

JULY 19, 2024

On June 12, 2024, Food and Drug Administration (FDA) issued exemptions for certain dispensers and in limited scenarios, their trading partners, from certain requirements of section 582 under the Food Drug and Cosmetic Act (FD&C Act) until November 27, 2026. Gathering transaction information for recalls at the package level.

Pharmacy Technician 45

Pharmacy Technician Documentation Communication Packaging 45

Pharmaceutical Technology

JUNE 17, 2025

Having a long-term partner, who can help build an ecosystem for the long term help, and this has been well documented in the US, he added. He cited the example of VIB’s work with Belgian biotech argenx to develop an asthma treatment, ARGX-118, which argenx will now further develop. Sign up for our daily news round-up!

Communication 59

Communication Hospitals Packaging Documentation 59

European Pharmaceutical Review

JANUARY 13, 2025

5 However, the benefits are well documented. Sustainable pharma packaging: breaking down the barriers to adoption Over two years it resulted in approximately 52,000 inhalers being returned, equating to approximately 305 tonnes of CO 2. 2024; 85: 1-9. Pulmonary Pharmacology & Therapeutics. Internet] The Aerosol Society.

Packaging 52

Packaging Community Pharmacies Documentation Pharmaceutical Companies 52

Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

PharmaTech

JUNE 6, 2025

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals.

Dosage 52

Dosage Drug Development Documentation Biosimilars 52

European Pharmaceutical Review

APRIL 14, 2025

In the UK, the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024 1 have passed through the UK legislative procedure and will apply from 23 July 2025. In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC).

Hospitals 52

Hospitals Documentation Packaging Communication 52

PharmaTech

JUNE 23, 2025

It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties. From the Dilantin package insert: “The free acid form of phenytoin is used in DILANTIN-125 Suspension and DILANTIN Infatabs. Mancini, A.

Compounding 52

Compounding Dosage Labelling Drug Development 52

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Despite the removal of some of the most controversial proposals, the final rule still contains a variety of significant changes, which become effective on November 19, 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.,

Vaccines 59

Vaccines Inpatient Packaging Documentation 59

Pharmacy Friday Pearls

AUGUST 29, 2022

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. Insulin [Lexi-drugs] Dextrose injection package insert High dose insulin therapy. Intensive care medicine , 33 (11), 2019–2024. Greene et al., Potassium was maintained within low normal range (3.8-4.0

Packaging 52

Packaging Documentation 52

PharmaShots

JUNE 1, 2023

These new results reinforce our differentiating data package for PDC*lung01. Eric Halioua: We forecast to get the final report of the current clinical trial (P-I/II PDC-LUNG-101 trial) in Q2 2024. Smriti: Please share the development timeline for the PDC*lung01, when can we expect the next phase of development?

Immunization 40

Immunization Immunity Vaccines Health and Personal Care Stores 40

PharmaVoice

JUNE 11, 2025

The 1,000-plus page document is full of tax and spending cuts, including some significant changes that will impact pharma and the larger healthcare industry. Plus, the package would require all rebates or discounts received by PBMs to be passed on to a Medicare Part D plan sponsor, according to a recent brief by Mintz.

Drug Pricing 179

Drug Pricing Packaging Documentation 179

BioPharma Dive

JUNE 12, 2025

The 1,000-plus page document is full of tax and spending cuts, including some significant changes that will impact pharma and the larger healthcare industry. Plus, the package would require all rebates or discounts received by PBMs to be passed on to a Medicare Part D plan sponsor, according to a recent brief by Mintz.

Drug Pricing 52

Drug Pricing Packaging Vaccines Documentation 52