Industry News
Sterility Concerns Cause Recall
Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.
FDA Releases Guidance on GDUFA Self-Identification
The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.
Researchers Propose a Portable Biomolecular Manufacturing Method
Researchers from the Wyss Institute explain a potential method for transporting and producing temperature-sensitive pharmaceuticals at a reduced cost.
EMA Determines Certain Drugs Safe from Zika Contamination
The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.
Trends Released from the CPhI Korea Conference
CPhI outlines trends from the conference in Seoul.
EMA Stops Import of Products from US Company
EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.
FDA Director Responds to Drug Pricing Concerns
In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.
Combination Products Challenge Regulators and Manufacturers
Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.
PhRMA Announces Research & Hope Award Winners
The organization announced the winners of the 2016 awards at a dinner on Sept. 13 in Washington DC.
FDA Issues Guidance on the Use of Plasma Fibrinogen Biomarker
The agency provides a qualified context of use for the biomarker plasma fibrinogen.
Compounder Cited for Sterile Manufacturing Violations
FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.
Biosimilars Face Repercussions of Drug Pricing Debate
Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.
Pan Drugs Limited Receives FDA Warning Letter
The Indian facility was cited for a range of quality and data integrity violations.
EDQM Publishes Elemental Impurities Guideline
The agency published a guideline for the implementation of ICH Q3D.
Quality Issues Found at Brazil Drug Manufacturing Facility
FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.
HHS Awards $8.2 Million to Moderna for Zika Vaccine Development
The department gave Moderna $8.2 million to accelerate development of an mRNA-based Zika vaccine.
A Global Fight Against Antimicrobial Resistance
Regulatory agencies meet to discuss approaches to the development of antibacterial agents.
SpacePharma SA Launches US Subsidiary
SpacePharma will give US researchers access to microgravity solutions to advance R&D projects.
ISPE Elects 2016–2017 Board of Directors
ISPE announced the results of its 2016–2017 International Board of Directors election.
Chinese Facility Receives Warning Letter
FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.
Industry Groups Applaud GDUFA Agreement
GPhA and PBOA commend agreement to reauthorize Generic Drug User Fee Amendments.
Competition and Drug Pricing
Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard
FDA Publishes Antibacterial Drug Development Guidance
The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.
FDA Publishes ANDA Submission Guidance
The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.
Quality Issues Cited at Frontida BioPharm
FDA issued a warning letter to the company for quality control violations.
FDA Finds Microbial Contamination at Drug Compounder
The agency sent a warning letter to Cape Apothecary for adulterated drugs.
Compounding Pharmacy Warned Over a Variety of Violations
FDA issued a warning letter to College Pharmacy for multiple violations.
CPhI’s Pre-Connect Congress Outlines Pharma Trends
CPhI Worldwide’s Pre-Connect Congress will discuss current trends in the pharmaceutical industry.
The CRISPR Patent Debate
The debate over who has control over patents for CRISPR gene-editing technology came to a head on August 17, 2016 after an email was released from a former graduate student at the Broad Institute accusing Harvard-MIT of wrongfully securing patents to the technology.
Sagent Pharmaceuticals Issues Nationwide Recall
The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.
