Doctors, FDA Approval and Packaging - Drug Discovery Digest

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies

Therapies FDA FDA Approval Treatment

Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

JANUARY 7, 2025

Explain the FDA Approval Process Many patients are unaware of the rigorous approval process generic drugs must undergo. Educate them about the FDA’s role in ensuring the safety and efficacy of generic medications. These anecdotes can help alleviate fears and build confidence in generic medications.

Drugs

Drugs FDA Doctors Trials

Dentitox Pro – Text Presentation

The Pharma Data

MAY 15, 2021

The product is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. After you fill in your information and confirm your package will be shipped for free right to your doorstep as soon as possible. Dentitox Pro is non-GMO and safe.

Production

Production Packaging Nurses FDA Approval

DermaPrime

The Pharma Data

MAY 16, 2021

Every capsule is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. If you order the 3 bottles or 6 bottles package (which we highly recommend as we estimate that we will run out of stocks soon as this has happened before) you’ll also take advantage of a huge discount.

Production

Production Nurses FDA Approval Packaging

Met Slim Pro

The Pharma Data

MAY 13, 2021

After all my requirements were 100% met, we finally had the final product: Every capsule is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards.Met Slim Pro capsules are non-GMO and safe. And I will be more than happy to share it with anyone who needs it.

Production

Production Packaging Doctors FDA Approval

AlphaZym Plus

The Pharma Data

MAY 13, 2021

That is why, with the help of my doctor and his connections, I managed to create a natural weight loss formula that is available for everybody. Every capsule is manufactured in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. AlphaZym Plus capsules are non-GMO and safe.

Production

Production Doctors FDA Approval Packaging

Which Arthritis Painkiller Works the Fastest?

The Pharma Data

MAY 13, 2021

WITHOUT doctors, physical therapists or chiropractors. Our Unique Solution Has Been Featured All Over The Media, From Hallmark, The Doctors, Atlanta Live & Arizona Midday…. I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! And then got my Doctor of Pharmacy (Pharm.

Pharmacy

Pharmacy Doctors Production Therapies

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Chicago, IL.:

Treatment

Treatment Therapies FDA FDA Approval

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. . April 2020.

Treatment

Treatment FDA Therapies FDA Approval

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. This has happened before with other drugs.

Clinical Trials

Clinical Trials Virus Vaccine Trials

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. 2023) ( here ).

Testimonials

Testimonials Drugs FDA Vaccine

Third Circuit Affirms Mass Dismissal In Throwback Decision

Drug & Device Law

AUGUST 3, 2023

To the contrary, as one of the panel noted in a concurrence, FDA approval of a drug’s labeling creates a presumption of adequacy. Plaintiffs did not even complain about the content of the package insert. The package insert is what most people think of as a prescription drug’s “label,” with its familiar format.

Doctors

Doctors Packaging FDA FDA Approval

No Liability for Not Manufacturing a Product

Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Genzyme Corp.

Production

Production FDA Approval Packaging Doctors

Drug Discovery Digest

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

Educating Patients about Generic Drugs: Strategies for Success

Trending Sources

Dentitox Pro – Text Presentation

DermaPrime

Met Slim Pro

AlphaZym Plus

Which Arthritis Painkiller Works the Fastest?

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

Making a “Miracle” HIV Medicine

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Third Circuit Affirms Mass Dismissal In Throwback Decision

No Liability for Not Manufacturing a Product

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