Industry News
FDA Names Industry Veteran as Director of Quality Office
Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.
FDA Releases Guidance on Generic-Drug Development
The agency releases guidance on controlled correspondences related to generic-drug development.
USP Previews New Compounding Standards
The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.
Compounding Pharmacy Issues Recall
US Compounding, Inc. issues voluntary recall of all sterile products.
FDA Promotes Its Scientific Mission
In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.
NIH Awards Grants for Genomics Research
Six grants from the NIH will help identify variants in the genome’s regulatory regions that affect disease risk, using new computational approaches.
EMA CHMP Chair Re-elected
Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.
New Zealand Manufacturer Cited for CGMP Violations
FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.
FDA Cites India API Facility For CGMP Violations
The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.
Johns Hopkins University Debuts New Protective Suit for Ebola Outbreaks
The protective suit was recently honored by Fast Company’s 2015 Innovation by Design Awards.
Confirmation for Califf?
The White House nominates Robert Califf to head FDA, but will he be confirmed?
Rob Califf Selected to Fill FDA Commissioner Post
President Obama will nominate Rob Califf, current deputy commissioner for medical products and tobacco, as FDA commissioner.
FDA Issues Final Elemental Impurities Guidance
FDA publishes the final Q3D Elemental Impurities guidance.
EMA Sets Up Workshop on Orphan Drugs
The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.
FDA Issues Guidance on Evaluation of Drug Toxicity
The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.
FDA Releases Guidance on Formal Disputes
The agency releases guidance on good review practice for formal dispute resolution in regards to appeals.
USP Partners with USAID to Secure Supply Chain
UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.
Sharing Project or Partnership Details
When should CMOs and their pharma clients share the details of their partnerships with outside parties?
AAPS Leadership for New Term Announced
Pharma scientists announced for AAPS executive council and section leadership positions.
Knowledge-Sharing and Networking at the CPhI Pre-Connect Congress
The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.
Biosimilars and Follow-on-Biologics Market to Hit $35 Billion Globally by 2020
Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.
Industry Responds to FDA Metrics Program
Manufacturers seek gradual rollout of more targeted FDA quality metrics program.
Reagan-Udall Foundation Builds Portfolio of Drug Regulatory and Safety Projects
The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.
Continued Process Verification Key to Lifecycle Control and Continuous Improvement
Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.
FDA Issues Guidance on Outsourcing Registration
The agency issues guidance for companies considering registering with FDA as an outsourcing facility.
Regulators Call for the Revision of Part B Reimbursement Rules for Biosimilars
The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.
Pfizer/Hospira Merger “Detrimental” to Infliximab Market
European Union regulators said Pfizer must divest its infliximab biosimilar candidate and some sterile injectables for the merger with Hospira to be completely approved.
Emergent BioSolutions to Split into Two Discrete Businesses
The new, still unnamed biosciences arm of Emergent BioSolutions will be a separate public company with a focus on novel therapeutics in immuno-oncology.
FDA Issues Dissolution Testing Guidance
FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.
FDA Outlines Fees for Drug Compounding Companies
FDA issues guidance regarding fees for drug compounding outsourcing facilities.
