Regulatory Authority Actions

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

The agency prepares a plan to implement new packaging safety features.

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

Can the feds negotiate Medicare Part D prices?

CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.

FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.

Amgen announces FDA will review the company’s BLA for ABP 501.

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.

FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

Abbott’s Compounding Pharmacy voluntarily recalls sterile products due to lack of sterility assurance.

Three associated centers in California, New York, and Florida are cited for not following proper sterilization and validation procedures and for not having the appropriate licenses to manufacture a biological drug product.

A US district judge entered a consent decree of permanent injunction on behalf of FDA, between the United States and pharmaceutical company, Downing Labs.

The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.

FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.

Traceability and transparency will remain elusive if manufacturers continue to approach serialization projects on a case-by-case basis.

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.

The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.

The agency has launched a new web platform to foster scientific innovation.

FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.

EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.

Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.

FDA approves Kanuma, the first treatment for patients with lysosomal acid lipase.

While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.

FDA confirmed quality focus while Congress moved to bolster biomedical innovation.