FDA Law Blog

AUGUST 16, 2022

These are called Pre-Approval Inspections, and, when COVID difficulties would otherwise delay inspections leading to drug approvals, numerous applicants have struggled with trying to expedite these inspections, or to convince FDA that the PAIs are unnecessary.

Manufacturing 98

Manufacturing Drugs Generic Drugs Licensing 98

pharmaphorum

OCTOBER 28, 2021

It has agree to a deal to supply the drug for around $700 per course with the US, but has also licensed the technology to generic drug producers so they can supply it more cheaply to low- and middle-income countries.

Generic Drugs 98

Generic Drugs Sales Drugs Licensing 98

Camargo

MAY 10, 2021

The guidance goes on to generally describes the tools and the mechanics of using the tools for programs, including (but not limited to) Pre-Approval Inspections (PAIs), Pre-License Inspections (PLIs), Post-Approval Inspections (PoAIs), Surveillance Inspections, Follow-Up and Compliance Inspections, and Bioresearch Monitoring (BIMO) Inspections.

Development 185

Development Clinical Trials Clinical Trials Trials 185

XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

Production 78

Production Insulin Branding Generic Drugs 78

Drug Channels

MARCH 15, 2022

Twice a year, I research and write two comprehensive, fact-based, and nonpartisan reports on drug channel economics. In some small way, I try to make the world a better and smarter place.

Pharmacy 98

Pharmacy Drugs Marketing Containment 98

Druggist

MARCH 8, 2021

In the UK, modafinil has narrow licensed use. The second licensed use of modafinil covers individuals who experience excessive sleepiness , defined as difficulty keeping wakefulness and an increased likelihood of falling asleep in inappropriate situations (eMC, 2020). Is modafinil a smart drug? Modafinil alternatives drugs.

Drugs 90

Drugs Licensing Licensing Doctors 90

pharmaphorum

MARCH 16, 2022

Viatris’ generic of Symbicort (budesonide and formoterol fumarate dihydrate) – developed by Viatris in collaboration with 3M spin-off company Kindeva Drug Delivery and called Breyna – has been cleared for the same indications as the brand, namely maintenance treatment for asthma and chronic obstructive pulmonary disease (COPD).

FDA Approval 59

FDA Approval Generic Drugs Marketing Drug Delivery 59

FDA Law Blog

AUGUST 29, 2024

After all, as we have written before in other contexts ( i.e. , the BLOCKING Act), “[I]f you limit a generic drug manufacturer’s ability to settle cases, that manufacturer does not settle fewer cases, it submits fewer Paragraph IV ANDAs. And fewer ANDAs means less, not more, generic drug competition.”

Production 59

Production Licensing Licensing Generic Drugs 59

Pharmacy Checkers

JANUARY 10, 2020

We know there are many doctors, nurses and other prescribing medical professionals who recommend PharmacyChecker or have learned of trusted licensed foreign pharmacies though their own research. Other medical professionals, however, are subject to the same scare tactics as consumers, ones perpetrated by drug company-funded organizations.

FDA Approval 62

FDA Approval Branding Pharmacy Manufacturing 62

pharmaphorum

FEBRUARY 2, 2022

The Netherlands biotech is developing leniolisib (formerly CDZ173) under license from Novartis for activated PI3K delta syndrome (APDS), an ultra-rare disease with no approved therapies that causes severe immune deficiency and a risk of blood cancers.

Trials 52

Trials Drugs Sales Generic Drugs 52

Pharmacy Checkers

DECEMBER 5, 2019

The DAL now allows online sales by “third-party platforms” of medicines approved in China, but they must register with the drug regulatory department. Such platforms could register properly licensed pharmacies that could sell their medicines by mail order, pursuant to other applicable pharmacy laws in China, such as prescription requirements.

Sales 64

Sales Medicine Pharmacy Drugs 64

FDA Law Blog

JULY 15, 2021

OPDP called out the use of this terminology in its letter: The above misleading claims and presentations are particularly concerning from a public health perspective because they could undermine confidence not just in Neulasta delivered via PFS but also in FDA-licensed biosimilar pegfilgrastim products, which are only delivered via PFS.

Production 52

Production Licensing Licensing Generic Drugs 52

FDA Law Blog

FEBRUARY 26, 2024

As FDA explains, Boehringer’s request would allow its “Cyltezo (adalimumab-adbm) injection, which contains the same total content of drug substance and same concentration as Original Concentration Humira (e.g., mg/mL) for liquid parenteral drug products. mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g.,

Production 59

Production Bioequivalency Drugs Containment 59

Druggist

SEPTEMBER 30, 2020

Both products contain the same drug – hyoscine butylbromide. The only difference comes in licensing of both products, which are reflected, for example by the broader availability of Buscopan IBS Relief and more stringent age restrictions for the product. Mebeverine is generally well tolerated with no common side effects listed.

Pharmacy 98

Pharmacy Containment Drugs Branding 98

FDA Law Blog

JULY 13, 2022

If that biosimilar has not been licensed or marketed within 1 year, the product may be eligible for a second year of delay if there remains a high likelihood of licensure and a significant amount of progress toward both licensure and marketing has been made since the receipt of initial request.

Manufacturing 52

Manufacturing Production Marketing Drugs 52

Pharmacy Checkers

DECEMBER 12, 2019

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” I agree with this 100%. assumes no additional health risks different from those present at a local Walgreens.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

Druggist

MARCH 17, 2021

Lymecycline is usually prescribed as a generic drug – lymecycline 408mg capsules or occasionally as a branded medication called Tetralysal 300 mg capsules. Both drugs are the same medicines. Although licensed for acne, minocycline is rarely prescribed in the UK. How does lymecycline work for acne?

Bacteria 59

Bacteria Dermatology Doctor Doctors 59

The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40

FDA Law Blog

APRIL 26, 2021

To balance these concerns, Congress delegated to FTC the authority to review and sign off on all generic drug and biosimilar patent settlement agreements based on a “rule of reason” standard established in the 2013 case, FTC v. In February 2017, FTC had the opportunity to test out the Actavis framework.

Marketing 40

Marketing Production Generic Drugs Drugs 40

FDA Law Blog

APRIL 26, 2021

To balance these concerns, Congress delegated to FTC the authority to review and sign off on all generic drug and biosimilar patent settlement agreements based on a “rule of reason” standard established in the 2013 case, FTC v. In February 2017, FTC had the opportunity to test out the Actavis framework.

Marketing 40

Marketing Production Generic Drugs Drugs 40

XTalks

AUGUST 2, 2023

AbbVie has also had some approvals made for their drugs, such as the European Commission approval of Skyrizi (risankizumab) and another FDA approval of Vraylar (cariprazine) , which marks the fourth indication for Vraylar, this time as an adjunctive therapy to antidepressants for major depressive disorder. billion, a 6.00 billion in 2021.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

MAY 4, 2021

Panzyga (immune globulin intravenous [human] ifas 10% liquid preparation) — In February 2021, Pfizer announced that the FDA approved the supplemental Biologics License Application (sBLA) for Panzyga to treat adult patients with a rare neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy (CIDP).

Vaccine 40

Vaccine Vaccination Production Sales 40

World of DTC Marketing

JANUARY 28, 2022

” Essentially, if certain circumstances are met, the government can act (“march-in”) and use its authority under the Bayh-Dole Act to grant a license to generic drug manufacturers to produce a drug in the United States—in this case,,, a generic version of Xtandi.

Drugs 284

Drugs Manufacturing Generic Drugs Licensing 284

Druggist

MARCH 25, 2021

This, however, does not come as a surprise since one of the requirements for licensing of generic medication is to provide the same products information leaflet as the branded drug’s leaflet. . New generic drugs are usually cheaper than original patent medicine, therefore switch in prescribing follows in the NHS.

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98

Druggist

OCTOBER 13, 2020

Truvada (emtricitabine/tenofovir disoproxil) is an antiviral drug used in the treatment of HIV, alone or as part of antiviral combination therapy. Truvada is also licensed as pre-exposure prophylaxis (PrEP) medication. One important message to take away is that Truvada and equivalent generic drugs are not 100% effective.

Generic Drugs 98

Generic Drugs Pharmacy Branding Doctor 98

FDA Law Blog

MARCH 13, 2024

The PTE application states “[u]nder the terms of the AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION LICENSE AGREEMENT between Pfizer Inc. exclusively licensed U.S. However, an exclusive license is not an authorization to rely on the activities of the marketing applicant for a PTE application. and OPKO Ireland Ltd.

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

The Pharma Data

MAY 6, 2021

FDA extends research agreement with MIT-licensed organ-on-chip systems ( Endpoints ). Sherrill, Kinzinger Lead Bipartisan Letter to House Appropriations Committee Urging Them Not to Block E-Labeling of Prescription Drugs ( Press ). million to resolve claims it paid drug kickbacks through charity ( STAT ).

Sales 52

Sales Vaccination Vaccine Gene Therapy 52

Pharmaceutical Technology

JANUARY 6, 2023

In the case of Novartis’ antihypertensive drug Exforge (amlodipine and valsartan), retail pharmacies including CVS, Walgreens, and two other plaintiff groups accused Novartis and Endo International’s Par Pharmaceutical unit of forming an illegal “reverse payment” agreement to delay the launch of less expensive generic versions of the drug.

Doctor 242

Doctor Doctors Drugs Sales 242

FDA Law Blog

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. Javitt & Jeffrey N. The concerns raised by PERA are not limited to these industries, however.

Gene 64

Gene DNA Genetics Gene Sequencing 64

Pharmacy Checkers

OCTOBER 11, 2019

It’s not entirely clear to me what drugs are permissible under Pathway II and it won’t be until the draft guidance is made public. The discussion below applies to brand-name (not generic) drugs. Drug companies make their products in many countries and ship those same drugs around the world to different markets.

FDA Approval 55

FDA Approval Drugs Manufacturing Pharmacy 55

FDA Law Blog

MARCH 31, 2025

1095 would authorize the Federal Trade Commission (FTC) to initiate a civil action against any person or entity that submits a baseless petition to FDA with the intent that the Agencys review of the petition would delay the approval of a generic drug, a biosimilar biological product, or certain other new drugs (see here ).

Production 64

Production Sales Licensing Licensing 64

Pharmacy Checkers

DECEMBER 26, 2019

Our niche is comparative pricing and the proper credentialing of international online pharmacies, which process prescription drug orders filled by licensed pharmacies in several countries, require valid prescriptions, and do not ship controlled drugs into the U.S. We also provide information about discounted U.S. Methodology.

Pharmacy 73

Pharmacy Drugs Branding Medicine 73

Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41