Regulatory Oversight and Compliance

FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.

The regulatory agency rejected the medication, citing various issues related to device use.

Momenta’s fill/finish contract manufacturer, Pfizer, was cited in the letter.

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

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

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

Process conditions can corrode stainless-steel surfaces, necessitating corrective and preventive maintenance.

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

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

Baricitinib (Olumiant) is the first JAK inhibitor licensed to treat rheumatoid arthritis in Europe.

Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.

EMA announces that the European Union’s PAS Register has received its 1000th upload.

Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.

FDA's Warning Letter to an Indian API manufacturer alleges cGMP violations and improper cleaning and validation

Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.

Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.

The warning letter cited GMP violations for finished drug products.

Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.

Reducing regulatory roadblocks requires more than the stroke of a pen.

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.

The authors look at challenges and considerations to continuously improve inspection efficiency.

In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.

Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.

FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.

As the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.

Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

FDA’s Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.