Generic Drugs

FDA’s Proposed Generic-Drug Labeling Rule: Ensuring Efficiency and Compliance

September 09, 2016

If FDA’s proposed generic-drug labeling rule is passed in 2017, generic drug companies would need documented processes for safety tracking and label updates.

Common Deficiencies in ANDAs for Dermatologic Drug Products

September 02, 2016

Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.

Industry Groups Applaud GDUFA Agreement

September 01, 2016

GPhA and PBOA commend agreement to reauthorize Generic Drug User Fee Amendments.

Competition and Drug Pricing

August 30, 2016

Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard

Fresenius Kabi Expands US Sterile Injectables Capacity

August 18, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.

EMA Adopts Biologics Pharmacovigilance Practices

August 15, 2016

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

The Industry Hopes Congress Approves PDUFA Program in 2016

July 27, 2016

FDA and industry seek speedy Congressional approval of new user fee plan.

Federal Court Weighs in on Biosimilar Patent Dance

July 08, 2016

A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.

Teligent Breaks Ground on Manufacturing and R&D Expansion

July 06, 2016

Teligent is expanding its manufacturing and R&D complex in New Jersey.

Study: Patients Who Have Reactive Responses to Infliximab Should Not Switch to Biosimilar Versions

June 15, 2016

A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.