Regulatory Filings and Submissions

The agency published four guidance documents regarding ANDAs and amendments to ANDAs.

Just as FDA strengthens ties between reviewers and plant inspectors, proactive manufacturers are involving different disciplines in preparation for FDA audits.

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

The approval marks the first biosimilar approved in the United States for treating cancers.

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

Eli Lilly and Incyte face a roughly 18-month application delay for rheumatoid arthritis drug, baricitinib, in the US with a request from FDA for additional clinical data.

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.

The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.

ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.

The agency announced a plan to eliminate its existing orphan designation request backlog.

The agency announced it is taking steps to increase competition within the prescription drug market.

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.

Approval of breakthrough therapies requires expedited quality assessment.

The agency released several new and revised guidance documents regarding product-specific generic drug development.

CPhI expert, Girish Malhotra believes drug costs could be lower if approval timeframes can be cut from 10 to three months.

The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.

FDA denies the NDA for the RA drug developed by Eli Lilly and Incyte, citing the need for more data.

Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.

A drop in US drug approvals was noted but this trend was not yet seen in Europe.

A new study in NEJM compares the regulatory review processes of FDA and EMA.

What are the pros, cons, and practicalities of moving pharma manufacturing back to the US? \

Deutetrabenazine is the first deuterated product approved by FDA, approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a decade.

GW Pharmaceuticals plans to submit a regulatory filing to FDA and EMA following two positive Phase III trials of Epidiolex in patients with Lennox-Gastaut Syndrome.

Will new generic drugs bring the cost of medicines down in the way policy makers hope?

The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.

President Trump calls for faster FDA approvals and lower drug prices.

The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.

In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.

The authors discuss regulatory and patent issues with combination products.