Regulatory Oversight and Compliance

A new study in NEJM compares the regulatory review processes of FDA and EMA.

What are the pros, cons, and practicalities of moving pharma manufacturing back to the US? \

Scott Gottlieb answers Senators' questions at his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.

Deutetrabenazine is the first deuterated product approved by FDA, approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a decade.

Both the European Union and United States are still ironing out issues such as confidentiality of information and recognition of competence of each party’s regulatory authorities in their agreement on GMP inspections.

GW Pharmaceuticals plans to submit a regulatory filing to FDA and EMA following two positive Phase III trials of Epidiolex in patients with Lennox-Gastaut Syndrome.

Industry fears limited benefits as FDA readies voluntary data tracking program.

The mAb is the first approved treatment that targets the progressive form of the disease.

The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.

Will new generic drugs bring the cost of medicines down in the way policy makers hope?

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

FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.

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

Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.

The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.

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.

Policies limiting imports and immigration generate uncertainty for US and foreign firms

Efforts to harmonize the fragmented regulatory framework for pharmaceuticals in the European Union continue to be a challenge.

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

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

The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.

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

The authors discuss regulatory and patent issues with combination products.

The district court ordered Pick and Pay Inc./Cili Minerals to cease operations after it unlawfully manufactured and distributed unapproved new drugs, misbranded drugs, adulterated dietary supplements, and misbranded dietary supplements.

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.

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.