Industry News

FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.

The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.

Human antibody for Zika virus could help in the treatment and prevention of the infection.

The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.

The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.

The White House said President Trump will nominate Scott Gottlieb to the position of FDA commissioner.

The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.

The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.

Dr. Janet Woodcock said implementation of Informatics Process Management is a priority during the latest Director’s Corner podcast.

The conference will include 55 speakers at more than 44 sessions.

A new software technology, CRISPETa, is designed to assist in the deletion of non-protein coding sections of DNA.

The UK Stem Cell Bank released validated stem-cell lines for researchers developing novel cell-based therapies for clinical trials.

President Trump calls for faster FDA approvals and lower drug prices.

The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.

FDA plans to initiate its quality metrics program as industry continues to push back.

Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.

The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.

In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.

The companies have developed a Level 4 traceability solution to manage pharmaceutical regulatory requirements.

The ICH Q11 Q&A discusses the development and manufacture of drug substances and the selection and justification of starting materials.

PhRMA submits comments to the The Office of the United States Trade Representative encouraging protection of US innovation in foreign markets.

FDA approved Valeant’s brodalumab with a boxed warning for suicidal ideation.

The Patent Trial and Appeal Board ruled in favor of the Broad Institute, allowing the company to keep patents for their CRISPR-Cas9 gene-editing technology.

FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.

South East Asian pharma manufacturers seeking region growth expected to attend CPhi South East Asia.

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.