FDA Law Blog

JULY 4, 2023

After FDA issues a final order under Section 505G of the Food, Drug, and Cosmetic Act, requestors who will be subject to the final order and sponsors of OTC monograph drugs that will be subject to the final order are eligible to request formal dispute resolution. A hearing for a final order is not a formal, trial-type, evidentiary hearing.

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FDA Law Blog

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. DASCA became law, amending the CSA, on December 18, 2014.

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.

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The Pharma Data

NOVEMBER 4, 2020

. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.

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FDA Law Blog

AUGUST 11, 2024

Presenting only information about the benefits or efficacy of a prescription drug, like AUVI-Q, without any risk information is considered a false or misleading presentation under the Federal Food, Drug and Cosmetic Act (FDCA), and is considered misbranding of the product.

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Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. 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. IMPORTANT SAFETY INFORMATION. Disclosure Notice.

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Delveinsight

FEBRUARY 22, 2021

opaque, contain zinc oxide or titanium dioxide, and may be cosmetically unacceptable to some patients. peptide small molecule, has completed phase II trials successfully meeting primary endpoints. The rarity of the disease makes it difficult for researchers to study, and run clinical trials for its therapies.

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The Pharma Data

DECEMBER 18, 2020

The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. The vaccine was 94.1% View original content to download multimedia: [link].

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Pfizer

AUGUST 15, 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. PAXLOVID is generally administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days.

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The Pharma Data

DECEMBER 28, 2020

Neither the CRL nor this subsequent records request identified or raised any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application. 1 An estimated 2.4 1 American Psychiatric Association. 5 th ed.

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XTalks

AUGUST 2, 2023

It contains the antiviral medications nirmatrelvir and ritonavir. This is largely due to failed trials as a prophylaxis resulting in the European Committee for Medical Products (CHMP) recommending against the approval of Lagevrio. Pfizer’s total global revenue from Paxlovid was $18.93 billion in 2022. billion in 2022. and $16,382.51

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FDA Law Blog

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.

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Pfizer

NOVEMBER 23, 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 information contained in this statement is as of November 23, 2022. Our Commitment to Access. IMPORTANT SAFETY INFORMATION. Disclosure Notice.

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FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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Eye on FDA

MARCH 10, 2021

As an agency, FDA issues Warning Letters from multiple sources covering a span of topics and concentrated on various segments of the subject matter jurisdiction of the agency – from food to devices to cosmetics and of course, to the communication by the manufacturers of medicine about their products.

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The Pharma Data

DECEMBER 31, 2020

Despite the claims from the Trump camp, multiple trials indicated that hydroxychloroquine was not effective. A trial in Brazil was also halted due to safety concerns. The idea is that the plasma, which contains antibodies against the virus, will be administered into patients who are critically ill.

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