FDA Law Blog

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). If the drug were legally marketed, the considerations may be different, and therefore CVM recommends that these sponsors “obtain an index listing, approval, or conditional approval.”

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The Pharma Data

DECEMBER 13, 2020

RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). SHP2 is a critical signaling node and regulator that promotes cancer cell survival and growth through the RAS pathway, playing a key role in the way cancer cells develop resistance to targeted therapies. About RLY-1971.

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks.

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World of DTC Marketing

MAY 24, 2022

DEA agents interviewed former Cerebral employees about clinician licensing issues and allegations that some patients had set up multiple accounts to obtain more drugs, Insider reported , citing sources. It means that mental help apps and services must be tightly regulated and reviewed. Does this mean we should give up?

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Advarra

APRIL 30, 2024

Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. In some countries, local regulations may indicate the sub-investigators need to sign as well.

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FDA Law Blog

FEBRUARY 26, 2024

314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” FDA explained that its bioequivalence regulations at 21 C.F.R. FDA borrowed this definition from 21 C.F.R.

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Production Bioequivalency Drugs Containment 57

Druggist

FEBRUARY 28, 2021

In other words, melatonin acts as a biological clock that regulates sleep. Melatonin, therefore, can be used to promote and regulate sleep (Wagner et al., In the UK, licensed forms of melatonin are prescribed either for the management of insomnia in adults over 55 years of age or to help with jet lag. Can buy melatonin abroad?

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FDA Law Blog

APRIL 3, 2022

Houck — Effective April 1, 2022, California Board of Pharmacy (“BOP”) regulations no longer require reporting every single missing tablet or dosage form. The prior BOP regulations became effective April 1, 2018, requiring owners to report the loss of any controlled substance, even single doses, to the Board. By Larry K. at § 1715.6(a)(2);

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Pharmacy Regulation Drugs Licensing 52

The Pharma Data

AUGUST 20, 2020

US regulators have approved Janssen’s Darzalex (daratumumab) in combination with carfilzomib and dexamethasone (DKd) for the treatment of adults with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. . Source link.

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The Pharma Data

DECEMBER 23, 2020

The Company advises that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 (or the SARS-2 Coronavirus) at this time. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. About NP-120 (Ifenprodil).

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FDA Law Blog

SEPTEMBER 18, 2024

FDA cited February 16, 2021, as the first date on which another manufacturer could have marketed its NMN-containing dietary supplement lawfully after submitting an NDIN to the Agency on December 3, 2020. The phrase in subsection (ii) “authorized for investigation as a new drug” is generally accepted to mean that an IND is in effect.

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The Pharma Data

JANUARY 18, 2021

In yesterday’s online edition of Forbes magazine, Ahmad Doroudian, CEO of BetterLife, further emphasized the significant barriers that current regulations impose on development of the current generation of psychedelics and LSD based compounds and advantages of non-controlled second generation psychedelics such as TD-0148A.

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The Pharma Data

DECEMBER 28, 2020

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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XTalks

JANUARY 28, 2022

Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators. Kimmtrak is a bispecific protein that contains a soluble T cell receptor fused to an anti-CD3 immune-effector function.

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Pfizer

APRIL 26, 2023

Our engineers created specially designed, temperature-controlled shipping containers (that we call “shippers”), which contain GPS temperature enabled trackers for continuous, real-time location and temperature monitoring and can maintain required temperature conditions for up to 10 days unopened.

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The Pharma Data

MARCH 14, 2021

This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.

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Vaccination Vaccine Licensing Licensing 52

XTalks

APRIL 24, 2023

Early and ongoing engagement with regulators greatly helps clinical development planning. Scientific advice meetings with regulators help ensure the trial design and gene therapy manufacturing will meet regulatory expectations. As a result, there are several EU regulations and directives to follow.

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Gene Therapy Gene Trials Clinical Trials 71

The Pharma Data

JANUARY 25, 2021

Further to the update outlined in the Company’s results for the year ended 31 December 2019, Secura Bio, Inc. (“Secura Bio”), the licensor of panobinostat, the API component of MTX110, has twice declined an invitation to withdraw its purported termination of the license. We are well positioned for a productive 2021.”

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Containment Drug Delivery Licensing Licensing 52

XTalks

APRIL 26, 2021

It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. Malaria Vaccine Phase II Trial.

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The Pharma Data

JANUARY 10, 2021

Monjuvi (R) is a registered trademark of MorphoSys AG. Tremfya (R) is a registered trademark of Janssen Biotech, Inc. For more information, please contact: SOURCE: MorphoSys AG via EQS Newswire. View source version on accesswire.com: [link]. Source link.

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The Pharma Data

JANUARY 12, 2021

With the phase of the Agreement relating to the development of the antibody completed, under the Agreement, as of 11 January 2021, GlobalCo has three months to exercise an option to license the Company’s intellectual property necessary to exploit the CDX antibody on an exclusive worldwide basis (“Option”). .

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The Pharma Data

MAY 14, 2021

Neither ClickBank nor the author are engaged in rendering medical or similar professional services or advice via this website or in the product, and the information provided is not intended to replace medical advice offered by a physician or other licensed healthcare provider. ClickBank is the retailer of products on this site.

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pharmaphorum

MARCH 26, 2021

Surprisingly, although the TCA is voluminous at 1250 pages, it is not comprehensive for most regulated industries. The TCA mentions medicinal products only fleetingly in its main body, but contains a specific Medicinal Products Annex. Andrew Shindler takes stock of the deal and considers potential future difficulties. .

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The Pharma Data

JANUARY 26, 2021

is a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9 billion by 2027. About Q BioMed Inc.

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Drugs Containment Production Marketing 40

FDA Law Blog

JANUARY 18, 2024

FDA had not approved any drug product for marketing containing marijuana so DEA applied a five-part test it had established when denying marijuana rescheduling in 1994. Dronabinol is a schedule I substance unless contained in FDA-approved Marinol (schedule III) or Syndros (schedule II). 21 U.S.C. § 802(16)(B).

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Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3, The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3,

Packaging 52

Packaging Packaging Drugs Containment 52

The Pharma Data

JANUARY 27, 2021

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

In-Vitro 52

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Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., For more information, please visit www.PAXLOVID.com. .

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Drugs Licensing Licensing Production 110

The Pharma Data

DECEMBER 20, 2020

This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

Drug Delivery 52

Drug Delivery Containment Production Development 52

The Pharma Data

JANUARY 10, 2021

Its products are intended to be licensed to players in the health sector. DISCLAIMER This press release contains forward-looking statements about VALBIOTIS’ objectives. Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic centers.

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The Pharma Data

DECEMBER 15, 2020

This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis. This disclosure contains information that Lipidor is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014).

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Contract Manufacturing Manufacturing Production Drugs 52

The Pharma Data

DECEMBER 12, 2020

Morgan Cazenove”) each of which are authorised by the Prudential Regulation Authority and regulated by the Financial Conduct Authority and Prudential Regulation Authority in the UK are each acting as financial adviser exclusively for AstraZeneca and no one else in connection with the matters set out in this announcement.

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Development Regulation Medicine Containment 75

Pfizer

DECEMBER 20, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., For more information, please visit www.PAXLOVID.com.

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FDA Law Blog

MAY 20, 2021

Investigators typically confirm with state authorities that the registrant has maintained required state professional and controlled substance licenses, and whether it has been the target of a state investigation. In our experience, investigators review copies of the registrant’s federal and state licenses.

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FDA Law Blog

MAY 20, 2021

Investigators typically confirm with state authorities that the registrant has maintained required state professional and controlled substance licenses, and whether it has been the target of a state investigation. In our experience, investigators review copies of the registrant’s federal and state licenses.

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The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. PharmaDrug Inc.

Drugs 52

Drugs Containment Development Clinical Development 52

Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Disclosure Notice The information contained in this statement is as of January 27, 2023.

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