The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40

Delveinsight

FEBRUARY 5, 2021

Rather, the bioequivalence studies were performed using the 150 mg strength; and the data was extrapolated to the higher dose. Two doses, bupropion XL 15 mg and bupropion XL 300 were approved. Since the higher dose was associated with the risks of seizures, the FDA granted a waiver in its testing.

Marketing 52

Marketing FDA Approval Branding Production 52

FDA Law Blog

JULY 9, 2024

For drugs, the relevant studies are any Phase 3 study or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies). . § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). For devices, the requirement is a bit more nuanced.

Clinical Trials 59

Clinical Trials Clinical Trials Development Drugs 59

Worldwide Clinical Trials

MAY 30, 2024

Differences in regulatory sentiments and industry sponsors’ subsequent clinical development strategies historically restricted access based on geography. This is administered according to the same treatment regimen as for the IV infusion. Initial approval in 2022: FDA, U.S.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

The Pharma Data

MAY 3, 2021

Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine ( Press ). UK Could Become ‘World Leader’ On Biosimilar Regulation ( Pink Sheet ).

Gene Therapy 52

Gene Therapy Vaccination Vaccine Bioequivalency 52