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Latest News & Analysis

Biocon, Dr Reddy’s Might Be Out Of The Woods On GMP Issue

Two Indian firms – Biocon and Dr Reddy’s – have received crucial establishment inspection reports (EIRs) from the US FDA amid improved compliance levels at their manufacturing sites.

Manufacturing Compliance

EMA Recommends New Approaches To Characterize Toxicity Of Anticancer Drugs

The European Medicines Agency has outlined new approaches for collecting and reporting of safety data to help better understand the toxicity and tolerability profiles of anticancer medicines. The new recommendations are published in an updated guideline that will apply from April 2018.

Safety Regulation

No More 'Hidden' Facilities, US FDA Tells Generic Sponsors

Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible for listing all facilities that could be used as part of ANDA.

Generic Drugs Review Pathway

FTC Scrutiny Of Profit Seeking In Drug Supply Chain In Fact-Finding Mode

Agency hears from experts on whether PBMs and group purchasing organizations operate under misaligned incentives.

Pricing Debate Legal Issues

US FDA Staff Slams Agency Hiring Policies In Report Ahead Of Public Meeting

Agency to discuss results of report, as well as pending 2018 pilot project designed to modernize its hiring practices.

FDA Leadership

Alex Azar And The Return Of Republican-Style Price Negotiation

The nomination of a former drug industry executive to run HHS is obviously good news for the biopharma sector, but it does not mean that HHS will do nothing about drug prices. On the contrary, it may make some high-profile action against pricing outliers all but inevitable.

Pricing Debate Policy

FDA's NDA And BLA Approvals: Juluca

Original new drugs and biologics recently approved by US FDA.
Approvals Regulation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

FDA’s Delay Issuing DSCSA Grandfathering Guidance Creating Problems For Manufacturers

US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for manufacturers and other parties in the pharmaceutical distribution chain.

Manufacturing Quality

Don't Sleep On DTC Compliance: FDA Dings Zolpimist Superiority Claim Vs Ambien

Warning letter objects to webpage and meeting exhibit material for excluding any risk information and suggesting mist formulation is superior to oral zolpidem products.

BioPharmaceutical Regulation

Will HTA Bodies Accept Your Innovative Trial Design?

Innovative trial designs add a new layer of uncertainty for health technology appraisal bodies. They are likely to adapt to a changing environment, but there could be a price for companies.

Clinical Trials Drug Approval Standards

European Commission Finally Delivers On GMP Standards For ATMPs

Following protracted consultations with stakeholders on how best to specify good manufacturing practice standards for advanced therapies, the European Commission has at last published the long-awaited guideline. The industry is now keen to work with EU inspectors and competent authorities to develop a common understanding of the risk-based principles outlined in the final document.

Manufacturing Europe
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