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Manufacturing

Set Alert for Manufacturing

The Reaction To Valsartan Impurities: More Scrutiny, More Testing And Tighter Limits

In the months since US and EU authorities restricted Zhejiang Huahai’s market access over the discovery of nitrosamine impurities in its valsartan API, the broader regulatory consequences for drug manufacturers are coming into focus.

Compliance Manufacturing Quality
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Latest From Manufacturing

FDA Final Rule Places Six Substances On 503A Bulks List; Rejects Four

FDA has issued its first-ever rule listing drug substances permitted for compounding under DQSA; the list contains few surprises and is unchanged from a proposed rule. The agency allows six bulk drug substances to be compounded by traditional pharmacies and rejects four that it had considered for inclusion, overruling the objections of pharmacy groups that argued for retaining them on the compounding list.

 

United States Manufacturing

How One Biotech Venture Is Breaking The Cost Barrier In Manufacturing MAbs For Infectious Diseases

Biotech official explains how creating partnerships with NGOs, using innovative cell cloning technology and cutting costs is allowing startup to develop new monoclonal antibody treatments for infectious diseases in developing countries, including a new MAb for Ebola.
Manufacturing Quality

Regenerative Medicine Therapies: Manufacturing Changes May Not Impact RMAT Designation

Final guidance notes that preliminary clinical evidence may come from studies conducted outside the US, says historical controls may be considered in clinical trial designs.

Clinical Trials Manufacturing

FDA Launches Pilot To Gain Practical Experience With 'Established Conditions' In Quality Assessments

FDA is accepting applications from the pharmaceutical industry to pilot the use of established conditions proposed by sponsors in NDAs, ANDAS, BLAs and supplements. The purpose of the pilot is for FDA to gain practical experience in assessing proposed established conditions and to ensure that assessment decisions do not negatively impact user fee time frames.

Manufacturing Quality

Deal On European SPC Manufacturing Waiver Is An Acceptable Compromise

A deal on the European supplementary protection certificate manufacturing waiver has been agreed by the European Council, Parliament and the European Commission, providing a concrete path for a regulation to move forward, albeit with compromises on several key provisions. Meanwhile, the European off-patent and brand industries remain at odds over the benefits of the waiver.

Europe Intellectual Property

Immunomedics Dodges Manufacturing Site Specifics In Quest For Cancer Breakthrough Approval

Biotech firm chooses words carefully to wind its way through site inspection findings and CMC review concerns in hopes of winning its first FDA approval for a breakthrough breast cancer treatment.

Quality Manufacturing
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