The US Food and Drug Administration’s (FDA) decision to delay serialisation regulations shows drug companies and contract manufacturers are still unprepared, say industry representatives.
The US FDA has told Repros Therapeutics Inc. a new trial is needed to prove oral Proellex is safe, prompting the firm to consider refocusing on a vaginally-delivered formulation of the endometriosis candidate.
The US FDA has revealed its work plan for implementing aspects of the 21st Century Cures Act, including an investment in in silico tools for use in clinical trials.
The US FDA has rejected Ocular Therapeutix’s eye pain treatment Dextenza for a second time, again citing concerns about how the drug is made and tested.
Elite Pharmaceuticals has halted trials of its reformulated opioid painkiller SequestOx (naltrexone and oxycodone hydrochloride) after disappointing bioequivalence data from a study testing the drug in combination with a high fat meal.
Failure to establish system suitability testing for heparin and heparin-related drugs has landed Shandong Analysis and Test Center a US FDA warning letter.
Industry delegates say the US Food and Drug Administration (FDA) is showing increased support for continuous manufacturing, a stance C-SOPS told us is quality control-driven.
CROS NT has announced a new clinical trial solution that enables sponsors to take a risk-based approach to site monitoring – a shift to which is driving company growth, says CEO.
The EMA has cleared Janssen to make the HIV drug Prezista (darunavir) using a continuous manufacturing (CM) process as well as the previously approved batch method.
Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.
The EMA says aligning antibiotic trial requirements with the US FDA and Japan’s PMDA should allow drug firms to conduct single global development programmes.
European regulators’ efforts to develop continuous manufacturing guidelines are not as advanced as their US counterparts according to delegates who attended a conference last month.
Rich Pharmaceuticals has selected a clinical trial site in Thailand at which it will conduct a Phase I/II trial in collaboration with the contract research organization (CRO) CMIC ASIA-PACIFIC, PTE. LTD. (CMIC).
The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”
The US FDA has refused to reapprove Sun Pharma Advanced Research LTD’s epilepsy drug Elepsia XR (levetiracetam) citing problems at its plant in Halol, India.
The US FDA has accused Vikshara Trading & Investments Ltd. of giving false statements about a strike to delay the inspection of an Ahmedabad API plant later found to be non-compliant.
Issues in the quality testing of drug substance and product were among eight observations cited in a Form 483 following an inspection at Biocon’s site last month.
The US FDA has identified problems at Dr Reddy’s generic drug manufacturing site in Bachupally, India according to a filing on the Bombay Stock Exchange (BSE).
The US FDA has handed Sun Pharmaceutical Industries Ltd a Form 483 detailing critical observations made during an inspection of its Dadra, India facility.
Certara has launched a new solution for preparing, analyzing, and submitting pharmacokinetic (PK) data in Clinical Data Interchange Standards Consortium (CDISC) format.
The US FDA completed an inspection of Aurobindo Pharma Limited’s manufacturing plant in Bachupally, Hyderabad yesterday, issuing the Indian drug firm with a Form 483 detailing six observations.
Discovery of data problems at Qinhuangdao Zizhu’s Hebei API plant indicates the firm did not follow a remediation plan agreed after a prequalification inspection in 2015 according to the WHO.
The US FDA has accepted a manufacturing and trial plan for Evoke Pharma's Gimoti, the nasal metoclopramide formulation that fell short in a Phase III trial last year.
The US FDA has completed its inspection of Dr Reddy’s API plant in Srikakulam, Andhra Pradesh and issued the firm with a Form 483 detailing two observations.
Fresenius Kabi wants Wockhardt to change a BSE filing it says does not accurately reflect its role in the production of a Zosyn generic recently approved in the US.
Pfizer CentreOne has recently expanded its fill-finish and highly potent solid oral dose service offerings at two of its contract manufacturing facilities as it aims to fulfill a promise to grow its capabilities.
The US FDA has issued AstraZeneca with a second CRL for its hyperkalaemia candidate Zs-9 after finding problems at a Texas facility operated by subsidiary Zs Pharma.
The US FDA has told Scynexis not to start trials of an injectable formulation of its candidate antifungal Scy-078 after several volunteers developed blood clots during a Phase I study.
