New Drug Approvals

JULY 18, 2025

Detailed numbers are provided by Genuine in the slides and the medication package insert. [14] 22] In the same month, China’s drug regulator (NMPA) decided to fast-track the approval process, labelling it a first-in-class medication. [14] 17] Azvudine is toxic to the reproductive system of rats and rabbit. 98 : 379–386.

RNA

thought leadership

MARCH 26, 2024

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation 1 to revise many of the currently applicable Regulations.

Pharmaceuticals

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. With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals.

Packaging

Agency IQ

MARCH 15, 2024

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. By 2028, the state will require the recycling of 30% of single-use packaging and food service ware.

Regulations

Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Regulatory Background: How things work now Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.

Marketing

Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. has a strong voice in the world. citizens; 2.

Pharmaceuticals

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations

The Premier Consulting Blog

MAY 4, 2023

The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product. At Premier Consulting, our team of pharmaceutical regulatory experts is helping clients understand the changing regulatory landscape related to ophthalmic drugs and devices.

FDA

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite. Originally developed in the 1970s to treat diabetes, these drugs—such as Ozempic, Wegovy, and Mounjaro—have become headline-makers for their ability to induce significant weight loss.

Treatment

Drug Target Review

JULY 18, 2023

If we look at the pharmaceutical industry’s discovery and development success rate over the last 20 to 30 years, it has not improved, staying stubbornly at around 10 percent. With support from pharmaceutical companies, ultimately, the answer to this question should be yes. Will systems like the NHS be able to deliver it?

Drug Development

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

Drug Target Review

AUGUST 7, 2024

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world.

Drug Development

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

Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

Regulations

The Premier Consulting Blog

APRIL 27, 2023

Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5

Packaging

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.,

Production

Agency IQ

NOVEMBER 20, 2023

readability of package leaflet, patient engagement). Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. The report recognized the potential for an electronic format for Product Information (i.e.,

Production

Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. A: Working in a pharmaceutical company is the best way to learn this. A: This does not usually happen.

Packaging

Altus Drug Development

MAY 31, 2022

Value-based medicines promise to change the way the pharmaceutical industry works. By changing the focus of healthcare from profits to the well-being of patients, the healthcare world can start a virtuous cycle that benefits patients, doctors, and pharmaceutical manufacturers alike. What are value-added medicines?

Pharmaceuticals

The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. President and Chief Executive Officer of Tonix Pharmaceuticals. About Tonix Pharmaceuticals Holding Corp. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products.

Vaccine

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. . The IND goes into effect; and .

Clinical Trials

The Premier Consulting Blog

NOVEMBER 16, 2022

Excipients are ingredients separate from a drug’s active pharmaceutical ingredient (or drug substance) that are added to products to impart various properties such as binders, fillers, solubilizers, carriers, and pH adjusters. Involving nonclinical/toxicology experts early on is key to reducing the package of studies as much as possible.

FDA

Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. The Orphan Regulation entered into force in January, 2000, outlining requirements for orphan designation and incentives, and establishing the EMA Committee for Orphan Medicinal Products (COMP).

Marketing

The Pharma Data

NOVEMBER 4, 2020

After voters approve the measures, the state legislatures usually will need to set up regulations in each state. NDMA is an organic chemical used in the making of liquid rocket fuel and can be a byproduct of manufacturing, including pharmaceuticals. Right now, 11 states have fully legalized marijuana, CNN noted.

Packaging

Agency IQ

SEPTEMBER 6, 2023

A warning letter represents the FDA’s determination that a manufacturer has “ significantly violated ” FDA regulations, including those related to current good manufacturing practices (CGMPs). What should the meeting request package include? The use of a table format is encouraged to organize information within the request package.

FDA

FDA Law Blog: Biosimilars

JULY 15, 2025

Kirschenbaum — The Calendar Year 2026 Medicare Physician Fee Schedule (PFS) proposed rule ( here ), which was issued yesterday by CMS, contained important amendments to the regulations on Medicare Part B average sales price (ASP) reporting. The payment limit for most Part B drugs is ASP plus 6 percent. with certain exceptions.

Regulations

Agency IQ

OCTOBER 6, 2023

France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027. These facilities are uniquely categorized under French law so that they may be regulated with greater oversight. agricultural activity, waste processing).

Pharmaceuticals

Agency IQ

JUNE 26, 2023

Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.The Orphan Regulation entered into force in January, 2000, outlining requirements for orphan designation and incentives, and establishing the EMA Committee for Orphan Medicinal Products (COMP). regulators.

FDA

Agency IQ

NOVEMBER 27, 2023

In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug. Investigations revealed that nitrosamine impurities were found in pharmaceutical products due to reasons outside API synthesis , through re-use of chemical precursors containing leftover contaminants. guidelines.

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

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Law Blog: Biosimilars

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA regulations, at 21 C.F.R. The difference at issue here is the fact that Vanda’s Hetlioz product includes braille writing on its packaging, with some accompanying language (“Do not cover Braille”), and the generic products’ labeling does not. 355(j)(2)(A)(v).

FDA

The Pharma Data

JANUARY 31, 2021

Ion channels are a class of integral membrane proteins that regulate the flow of ions across the cell membrane as a means of conducting signals between cells and their environment. . TOKYO and CAMBRIDGE, England , Feb. Sosei Heptares is headquartered in Tokyo, Japan with corporate and R&D facilities in Cambridge, UK.

Structure Based Drug Design (SBDD)

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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. References Pratt CB, Alsarraj MA. Labcompare.

Therapies

Agency IQ

AUGUST 11, 2023

BY KARI OAKES AUG 7, 2023 10:20 PM CDT Quick background on nitrosamines in pharmaceutical products Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today. In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug.

FDA

Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. Industry wants its products reviewed quickly, efficiently and predictably.

FDA