A Florida company is recalling 26 sexual enhancement and diet pills after the US FDA discovered some contain undeclared active pharmaceutical ingredients (APIs).
The EU needs to better define mercury limits for drugs and dietary supplements say Polish researchers who want pharmaceuticals in Europe to be tested more regularly.
Sandoz has joined biosimilar developers calling on the US FDA to provide clear guidance on interchangability just a day after launching Zarxio, its Neupogen (filgrastim) copycat.
Update - Wholesale cost of Zarxio will be 15% less than Amgen's Neupogen
The US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products.
New US drug shortages this year are running roughly at the same levels as the last two years, and far below the record highs seen earlier this decade, the US FDA told in-Pharmatechnologist.
The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.
Drugmakers trying to make blue or green pills for the US market have a new option after the FDA approved a bacteria-derived extract developed by Colorcon for pharma applications.
The annual announcement of FDA user fees has brought scrutiny on the price tag for generic drug applications, as the approval backlog is almost a year longer than in 2012.
New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.
Pharma firms may need to carry-out an analytical method comparability study as part of the life cycle management of a drug, according to final US FDA guidelines.
Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.
Demand for West’s wearable injector - which uses the recently-approved Crystal Zenith delivery system - has led to the expansion of a facility in Arizona.
Following an FDA inspection in March, Catalent’s Center of Excellence for Analytical Services in Morrisville, NC was hit with a Form 483 with six observations.
Generic pills are a safety risk if they are too different from their reference drug according to the US FDA, which wants developers to consider physical characteristics when making copycat meds.
Raffles PharmaTech has contracted ScinoPharm to make the API for a generic version of the arthritis pain drug celecoxib being developed for the US market.
A Jubilant HollisterStier sterile manufacturing facility hit with a warning letter in 2013 has been upgraded following inspections by the US FDA last year.
Despite increased scrutiny from regulators, one third of Indian pharma manufacturers and CMOs have yet to conduct a review to assess potential gaps in the assurance of data integrity, according to a new EY survey.
The new draft guidance from the US FDA seeks to address the lack of clarity around when new chemistry, manufacturing, and controls (CMC) information must be reported to the agency.
Toronto, Canada-based SB Medical Inc. and Barbados-based TC Medical Group, as well as Hanoch Stein of Baltimore plead guilty last week to a multi-year operation to smuggle and sell misbranded prescription pharmaceuticals and unlicensed wholesaling of...
Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application reviewers, according to a report from the HHS Office...
Inaccurate and incomplete information on excipients referenced in the US FDA Inactive Ingredient Database (IID), as well as other agency policies and guidance on the review of inactive ingredients in ANDAs (Abbreviated New Drug Applications) “continue...
The US FDA has hit cancer-drug API maker Yunnan Hande Bio-Tech with a warning letter citing concerns over potential manipulation of quality test data at a plant in China.
To benefit from breakthrough therapy designation (BTD) pharma companies must be willing “bet on the right data” according to Roche, which says this could be a challenge for smaller firms.
The reputation of Indian clinical trials has been damaged by the “unjustified” suspension of medicines tested by GVK Biosciences, Pharmexcil says as it attacks the evidence submitted by French regulators.
The Director of the new 'super' Office of Pharmaceutical Quality must address issues surrounding increasing globalisation and manufacturing complexity, the FDA says as it begins the recruitment process.
Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.
Parexel’s audits of Ranbaxy’s deficient manufacturing operations in India were of specific interest to the FDA, though the CRO did not turn over the reports because of concerns that their release might damage the confidentiality of the company’s audit...
The CMO (contract manufacturing organization) industry is ripe for consolidation as the rise in outsourcing continues and clients look to simplify their supply chains, DPx CEO James Mullen told Outsourcing-Pharma.com on Wednesday.
Despite slamming the US FDA for tentatively approving two Ranbaxy ANDAs (abbreviated new drug applications) for the first Nexium and Valcyte generics, US District Judge Beryl Howell said last week the agency can revoke the approvals because of manufacturing...
Speciality Compounding has been ordered to cease production by the US Courts after tests confirmed injectable drugs made at its facility in Texas were contaminated by bacteria.
Patients who mix Chantix with alcohol can become aggressive or suffer memory loss says the US FDA, which has ordered Pfizer to update the smoking cessation drug’s side-effects label.
The SEC’s enforcement director is calling out pharma companies for failing to disclose and misinforming investors about correspondence with the US FDA.
